Anthogyr Axiom Plural Definitive Abutments Operating instructions

1/6

en – Instructions for Use – Axiom® plural definitive abutments

0459

Anthogyr SAS

2237 Av. André Lasquin

74700 Sallanches – France

www.anthogyr.com

E-mail: contact@anthogyr.com

Phone: +33(0)4 50 58 02 37

Validity Date : 2022-05

REF: 063PROTH-PLUR_NOT

Index: A

Axiom® plural denive abutments

Instrucons for Use

1. Product descripon

The Axiom® plural abutments range includes deni-

ve abutments, castable copings, locks and screws.

It also includes temporary components required for

denive restoraon: protecve cap & try-in locks.

The instrucons for use are valid for the following

Axiom® components:

▪Multi-Unit abutments

▪Multi-Unit protective caps

▪Multi-Unit copings

▪inLink® abutments

▪inLink® locks for inLink® prosthesis

▪Prosthetic screws for customized prosthesis

A denive prosthec screw is supplied with angu-

lated Mul-Unit abutment and Mul-Unit copings,

in the same packaging.

Materials:

Mul-Unit abutments, Mul-Unit protecve cap,

Titanium Mul-Unit copings, inLink® abutments,

inLink® locks and screws are made of Titanium-6Al-

uminium-4Vanadium ELI alloy:

Chemical components Composion, % (mass/mass)

Aluminium 5.50 to 6.50

Vanadium 3.50 to 4.50

Iron ≤ 0.25

Oxygen ≤ 0.13

Carbon ≤ 0.08

Nitrogen ≤ 0.05

Hydrogen ≤ 0.012

Titanium Balance

Denive prosthec screws and inLink® locks are

DLC (Diamond Like Carbon) coated.

CoCr Mul-Unit copings are made of Cobalt-Chro-

mium alloy (CoCr28Mo):

Chemical components Composion, % (mass/mass)

Chromium 28.00 ± 2.00

Molybdenum 6.00 ± 1.00

Chemical components Composion, % (mass/mass)

Iron ≤ 0.75

Manganese ≤ 1.0

Silicon ≤ 1.0

Carbon ≤ 0.14

Nickel ≤ 1.00

Nitrogen ≤ 0.25

Cobalt Balance

Specicaon about the melng range: 1390°C to

1415°C

CoCr Mul-Unit copings also include a castable part

made of Polymethyl methacrylate (PMMA).

inLink® locks on carrier are also made of Poly-

etheretherketone (PEEK):

Chemical components Composion, % (mass/mass)

Polyetheretherketone 100

Castable Mul-Unit copings are made of Polymethyl

methacrylate (PMMA)

2. Intended use

Mul-Unit abutments are intended to be placed into

Axiom® implants to provide support for screw-re-

tained restoraons aer oral implantaon.

inLink® abutments include an inLink® connecon and

are intended to be placed into Axiom® BL implants

to provide support for inLink® screw-retained res-

toraons aer oral implantaon.

Mul-Unit copings are intended to support the res-

toraon and t the coronary parts of the Mul-Unit

abutments aer oral implantaon.

Mul-Unit protecve caps are intended to protect

the coronary part of the Mul-Unit abutment aer

oral implantaon and maintain, stabilise and form

the so ssue during the healing phase.

InLink® locks are intended to be placed into Axiom®

TL implants or inLink® abutments to provide sup-

port for inLink® screw-retained restoraons aer

oral implantaon.

Prosthec screws for customized prostheses are in-

tended to be placed into Axiom® TL dental implants

or Mul-Unit abutments to screw-retain the custom-

ized restoraon aer oral implantaon.

3. Indicaons

Mul-Unit abutments are indicated to support de-

nive mulple-unit screw-retained restoraons on

Axiom® BL and/or Axiom® TL dental implants.

InLink® abutments are indicated to support denive

full-arch screw-retained restoraon on Axiom® BL

and/or Axiom® TL dental implants.

Mul-Unit copings are indicated to be part of a mul-

ple-unit restoraon and t this restoraon onto the

coronary parts of the Mul-Unit abutments.

Mul-Unit protecve caps are indicated to be placed

aer Mul-Unit abutments placement. Mul-Unit

protecve caps protect the coronary parts of the

Mul-Unit abutments and maintain, stabilise and

form the so ssue during the healing phase. They

have a maximum duraon of usage of 180 days.

InLink® locks are indicated to support inLink® de-

nive full-arch screw-retained restoraons on the

assembly of Axiom® BL dental implants & inLink abut-

ments and/or Axiom® TL dental implants.

Try-in inLink® locks are intended to be placed into

Axiom® TL implants or inLink® abutments to try the

prosthesis directly in the paent mouth aer oral

implantaon.

Mul-Unit

abutments

Mul-Unit

protecve caps

Mul-Unit copings InLink® abutments InLink® lock for inLink® prosthesis Prosthec screws for customized

prosthesis

Try-in locks Denive inLink®

locks

Denive inLink®

locks on carrier

Axiom® BL Axiom® TL Mul-Unit

abutments

Axiom® BL Axiom® TL

inLink® abutments

Axiom® TL Mul-Unit

abutments

en – Instructions for Use – Axiom® plural definitive abutments

2/6

Prosthec screws for customized prostheses are in-

dicated to screw-retain denive customized mul-

ple-unit restoraons on Axiom® TL dental implants

or Mul-Unit abutments.

Indicaon

Mulple-unit Complete

Axiom® BL

Mul-Unit abutments ● ●

Mul-Unit copings ● ●

inLink® abutments ●

Axiom® TL

Mul-Unit abutments ● ●

Mul-Unit copings ● ●

inLink® locks ●

Prosthec screws for

customized prosthesis ● ●

4. Paent type and intended user

Mul-Unit abutments, Mul-Unit copings, inLink®

abutments, locks and screws are intended for adults

requiring a mulple-unit or full arch tooth resto-

raon and who do not present any of the condions

menoned in the “Contraindicaons” secon.

The prosthesis must be used by a surgeon trained

in dental implantology.

5. Contraindicaons

Allergy or hypersensivity to chemical components

in the materials used and menoned in the “Product

descripon” secon.

Mul-Unit abutments must not be used for unitary

restoraon and/or if the implant divergence is great-

er than 40° between two implants: risk of impossible

inseron of the prosthesis.

Axiom BL straight MU abutment Ø4.0 H0.75 is contra-

indicated for placement in posions 3,4,5,6,7 and 8.

InLink® abutments must not be used for unitary res-

toraon or paral restoraon or implant-supported

overdenture with a prefabricated bar aachment

system.

6. Warning

Implant surgery is a complex dental procedure. In-

correct techniques can cause implant failure and/or

loss of bone support.

Appropriate training and qualicaon and a good

knowledge of surgical techniques with Anthogyr prod-

ucts are required. Anthogyr oers specic training.

Mul-Unit copings contain Cobalt. Cobalt is classied

as a hazardous substance. Anthogyr has conducted

a benet-risk assessment on Cobalt contained in

Anthogyr CoCr alloy. The overall conclusion of this

assessment is that the Anthogyr material is safe, pro-

vided that the amount of restoraons placed into a

paent does not exceed 13 units.

However, in the interest of your paent please con-

sider alternave soluons.

7. Cauon / Precauon

Clinical use:

▪Single-use devices: do not reuse or re-sterilise.

Risk of contamination and risk of alteration of the

functional surfaces.

▪

It is important to perform a pre-clinical assessment

and treatment plan that takes into account the

anatomical constraints of the future restoration.

▪The permanent prosthetic component must be

fixed on a sufficiently stable implant.

▪As far as possible, the prosthetic parts must be

firmly fastened to avoid the inhalation or swallow-

ing of parts during intraoral use.

▪

The prosthetic components must not be tightened

with a rotating power instrument.

▪

Laboratory, try-in or definitive inLink® locks should

not be put in the oven.

▪Do not use a prosthetic part after the expiry date

indicated on the packaging.

Component rework:

Mul-Unit copings:

▪Castable coping: screw channel (up to the screw

head) can be reworked.

▪CoCr coping: only the castable part can be re-

worked. The resin and casting should be thicker

than 0.7 mm prior to casting and can be trimmed

to a thickness of up to 0.5 mm after casting.

▪PACIFIC coping: only the castable part can be re-

worked.

The other components must not be reworked in

any way.

Safety informaon regarding magnec

resonance imaging (MRI):

The safety and compability of Anthogyr devices that

remain in the paent ’s body have not been evaluated

in the magnec resonance (MR) environment. They

have not been tested for heat build-up, migraon

or artefacts in MR environments. The safety of An-

thogyr devices in an MR environment is unknown.

Per forming an MRI examinaon on a paent wearing

such a device may result in injury.

8. Residuals risks and side eects

The clinical outcome of dental treatment is inu-

enced by mulple factors. The following residual

risks and possible side eects are related to the

use of Mul-Unit abutments, Mul-Unit copings,

inLink® abutments, locks and screws and may lead

to addional dental treatment at the dental pracce:

Residual risks:

▪additional treatment at dentist’s office

▪bite / mastication / phonetic problems

▪bone damage

▪damage to adjacent/opposing tooth

▪discomfort

▪hyperplasia

▪hypersensitivity / allergic reaction

▪implant fracture

▪injuries of gingiva

▪irritation / inflammation

▪local or systemic infection (including peri-implan-

titis, periodontitis, gingivitis, fistula)

▪local pain

▪longer recovery / healing time than expected

▪loss of implant

▪loss of prosthetic component

▪poor aesthetic outcome

▪possibility of prolongation of surgery

▪possibility of surgical implant explantation

▪possibility to swallow / inhale small parts during

the procedure

▪recall to the dentist’s office

Side eects:

▪swelling

▪local inflammation

▪bruising

▪resorption of maxillary/mandibular ridge bone

▪local infection

▪minor bleeding

9. Compability informaon

IMPLANT ABUTMENT SECONDARY PART SCREW

Type of implant Type of connecon Type of abutment Compable instruments Compable secondary

parts

Screw reference Compable instruments

Axiom® BL Conical

Mul-Unit abutments Mul-Unit screwing

instruments

Mul-Unit protecve caps -Hexagonal instruments

Mul-Unit copings MU140

Simeda® customized

prosthesis with angulated

access

MUAA140

Ball instruments

inLink® abutments Axiom® TL screwing

instruments -ILLXX0

ILLGXX0

Axiom® TL

M2.8 connecon (inLink®) inLink® prosthec - - ILLXX0

ILLGXX0 Ball instruments

M1.6 connecon (at) Mul-Unit abutments Mul-Unit screwing

instruments

Mul-Unit copings MU140 Hexagonal instruments

Simeda® customized

prosthesis with angulated

access

MUAA140 Ball instruments

Indexed M1.6 connecon

(at)

Simeda® customized

prosthesis - - TS160P Hexagonal instruments

en – Instructions for Use – Axiom® plural definitive abutments

3/6

Anthogyr implants and prosthec components are

available in a wide variety of conguraons. Only

Anthogyr par ts that are compable with the implant

connecon are suitable for use. For more informa-

on, please refer to the manuals listed in the “Further

informaon” secon.

An Axiom® BL implant can be made compable with

an Axiom® TL implant through the use of an InLink®

abutment.

CoCr casng alloy used must always have a lower

melng point than the CoCr used for the CoCr coping.

10. Cleaning and disinfecon

Sterile components:

Anthogyr sterile prosthec components are supplied

sterile (GAMMA sterilisaon) in blue packaging and

are idened with a S logo. They are intended

for single use. Do not clean or sterilise the prosthec

components. Cleaning, disinfecon and sterilisaon

can compromise the essenal material and design

features of the prosthec components and result

in device failure.

Non-sterile components:

Anthogyr non-sterile prosthec components are

supplied in white packaging and are idened with

a F logo. Before treatment, remove the compo-

nents from their packaging. Do not use the compo-

nents if the packaging is opened or damaged. They

must be cleaned and decontaminated before use and

aer each use for reusable components. Anthogyr

recommends following the protocol described in the

“cleaning and sterilizaon” manual available at ifu.

anthogyr.com or on request from Anthogyr at the

above address.

For sterilisaon, see the “Sterilisaon” secon.

Specic CoCr copings cleaning:

For the CoCr copings, please use the manual cleaning

protocol as described in the “cleaning and steriliza-

on” manual available at ifu.anthogyr.com or on

request from Anthogyr at the above address.

11. Sterilisaon

Sterile components:

For sterile prosthec components, check that the

enre packaging of the device is undamaged before

opening. Prosthec components with a damaged

packaging must not be used. It is recommended to

have a replacement component readily available for

use. The intact blister pack protects the sterilised

prosthec component against any external inuence

and, if stored properly, guarantees sterility unl the

expiry date. The blister pack must not be opened

before use of the prosthec component. When re-

moving the prosthec component from the sterile

packaging, asepsis rules must be followed.

Anthogyr declines all responsibility for re-sterilised

components, regardless of who carried out the

re-sterilisaon or the method used. Under no cir-

cumstances should a previously used or non-sterile

prosthec component be placed in the paent’s

mouth. If the original packaging is damaged, Anth-

ogyr will not accept the return of the content.

Non-sterile components:

Anthogyr prosthec components delivered non-sterile

must be sterilised before use. Anthogyr recommends

following the protocol described in the cleaning and

sterilisaon manual available at ifu.anthogyr.com or

on request from Anthogyr at the above address.

Aer the sterilisaon was done, asepsis rules must

be followed.

12. Protocol for use

Refer to the brochures listed in the “Further informa-

on” secon for detailed step-by-step instrucons.

A. Mul-unit

Step A1: Place the Mul-Unit abutment

Before screwing the abutment, ensure that the con-

necon is free of any uid or other substance that

may compromise the proper t of the prosthec

component in the implant.

Ensure that the Mul-Unit pre-assembled gripper is

correctly placed on the Mul-Unit abutment before

placing it in the mouth.

If the mouth opening is narrow, remove the pre-as-

sembled gripper from the Mul-Unit abutment and

use the short gripper instead.

Over-ghtening the abutment can deteriorate the

implant connecon and/or break the abutment.

Insucient ghtening of the abutment may result in

the abutment falling into the paent’s mouth.

▪Straight Multi-Unit abutment

▪Pre-screw the Multi-Unit abutment into the im-

plant with the gripper.

▪Remove the gripper from the Multi-Unit abut-

ment.

▪

Tighten the Multi-Unit abutment to 25 N.cm with

the Multi-Unit wrench and the prosthetic dyna-

mometric wrench or with the Multi-Unit mandrel

and the TORQ CONTROL®.

▪Angulated Multi-Unit abutment

▪Place the Multi-Unit abutment into the implant

with the gripper.

▪Tighten the Multi-Unit M1.6 screw to 25 N.cm

with the hexagonal wrench and the prosthetic

dynamometric wrench or with the hexagonal

mandrel and the TORQ CONTROL®.

▪Remove the gripper from the Multi-Unit abut-

ment.

Step A2: Protect the Mul-Unit abutments during

healing phase

▪Clean the Multi-Unit abutment coronary parts

thoroughly.

▪Tighten manually <10 N.cm without forcing the

protective caps onto the Multi-Unit abutment

coronary parts with the manual surgical wrench.

▪Suture around the protective caps to begin the

healing phase.

▪After the healing phase, connect the manual sur-

gical wrench to the protective caps.

▪Unscrew them from the Multi-Unit abutments.

Step A3: Prosthesis construcon

(dental laboratory)

To perform the prosthesis work, use the laboratory

screws and keep denive screws for clinical use.

Build the denive prosthesis:

▪By using castable copings

▪Use the castable copings as support for making

the wax restoration on the master model.

▪Make the metallic restoration according to cur-

rent casting and finishing protocols.

▪By using CoCr copings

▪Use the castable parts (fixed on the copings) as

support for making the wax restoration on the

master model. The wax should be applied across

the entire surface of the CoCr copings in order

to overcast correctly the CoCr copings. The CoCr

casting alloys used must comply with NF EN ISO

22674.

▪Make the metallic restoration according to cur-

rent overcasting and finishing protocols. The

CoCr copings alloy characteristics are available

in §1.

▪By using PACIFIC copings

▪Use the castable parts (fixed on the copings) as

support for making the wax restoration on the

master model.

▪Make the metallic restoration according to cur-

rent casting and finishing protocols.

▪Glue the copings into the restoration.

▪Reposition and screw the restoration onto the

master model and let it dry.

Step A4: Place the prosthesis onto the Mul-Unit

abutments

Before screwing the prosthesis, ensure that the

Mul-Unit abutments are free of any uid or other

substance that may compromise the proper t of the

prosthec component on the Mul-Unit abutments.

Over-ghtening the screw can deteriorate the abut-

ment connecon and/or break the screw.

Insucient ghtening of the screw may result in the

screw and/or the prosthesis falling into the paent ’s

mouth.

▪Prosthesis with straight screw channels

▪Clean and sterilise (See §Cleaning and disinfec-

tion and §Sterilisation) the prosthesis and defin-

itive M1.4 screws.

▪Position the prosthesis in the mouth.

▪Tighten the definitive M1.4 screws to 15 N.cm

with the hexagonal wrench and the prosthetic

dynamometric wrench or with the hexagonal

mandrel and the TORQ CONTROL®.

▪

Perform a control X-ray to check the passive fit of

the prosthesis on Multi-Unit abutments.

▪Close the screw channels.

▪Prosthesis with angulated screw channels

▪Reception of the Simeda machined prosthesis.

▪Clean and sterilise (See §Cleaning and disinfec-

tion and §Sterilisation) the prosthesis and defin-

itive M1.4 AA screws.

▪Position the prosthesis in the mouth.

en – Instructions for Use – Axiom® plural definitive abutments

4/6

▪

Tighten the definitive M1.4 AA screws to 15 N.cm

with the ball wrench and the prosthetic dynamo-

metric wrench or with the ball mandrel and the

TORQ CONTROL®.

▪

Perform a control X-ray to check the passive fit of

the prosthesis on Multi-Unit abutments.

▪Close the screw channels.

B. InLink® abutments

Step B1: Place the inLink® abutment

Before screwing the abutment, ensure that the con-

necon is free of any uid or other substance that

may compromise the proper t of the prosthec

component in the implant.

Over-ghtening the abutment can deteriorate the

implant connecon and/or break the abutment.

Insucient ghtening of the abutment may result in

the abutment falling into the paent’s mouth.

▪Insert the inLink® abutment into the Axiom® BL

implant with the Axiom® TL screwing instruments.

▪Tighten the inLink® abutment to 25 N.cm with the

inLink® wrench and the prosthetic dynamometric

wrench or with the inLink® mandrel and the TORQ

CONTROL®.

Step B2: inLink® prosthesis concepon

See the Step C1

Step B3: inLink® prosthesis construcon (dental

laboratory)

See the Step C2

Step B4: Place the inLink® locks into the inLink®

prosthesis

See the Step C3

Step B5 (oponal): Try the inLink® prosthesis

See the Step C4

Step B6: Place the inLink® prosthesis onto the

implants/abutments

See the Step C5

C. InLink® locks for inLink® prosthesis

Step C1: inLink® prosthesis concepon

▪Scan the platforms with the scan adapters and a

laboratory scanner approved by Anthogyr.

For more informaon, please refer to the manuals

listed in the “Further informaon” secon.

▪To minimize the vestibulolingual width of the

prosthesis, align the laser markings on the scan

adapters with the centre of the restorative space.

▪Design the framework using CAD software or a

wax-up on temporary abutments.

▪Up to 25° angulated access.

▪Minimum height of the prosthesis: 4.2 mm

▪

Minimum width of the prosthesis: ellipse of 4.5 x

5.2 mm

▪Send the file or wax-up to Anthogyr SA Mersch to

have the prosthesis milled.

Step C2: inLink® prosthesis construcon

(dental laboratory)

To perform the prosthesis work, use the laboratory

locks and keep denive locks for clinical use.

Build the denive prosthesis:

▪Reception of the Simeda machined frame.

▪

Before modifying or sandblasting the milled frame-

work protect the inLink® connection with the pro-

tective caps.

▪After the building of the prosthesis, disassemble

the protective caps.

▪Brush and then steam-clean the connections and

screw channels of the prosthesis.

Step C3: Place the inLink® locks into the inLink®

prosthesis

To facilitate inser on, we recommend aaching two

nal guiding locks to the framework. The guiding

locks should be used on implants that have a rela-

vely small divergence (max. 15°).

▪inLink® locks delivered alone

▪Using the “IN” side of the inLink® tool.

▪Remove the cap.

▪Place the lock in the retaining ring.

Important: when inserng the ring into the xa-

on lock, make sure that the square notches in

the ring point toward the p of the lock.

▪Clip the assembled lock and ring into the inLink®

tool.

The lugs on the inLink® key must sit in the notches

of the ring.

▪Put the cap back on the key.

Push the inLink® tool into the cap.

▪Turn slightly until the head of the lock appears.

▪Push the lock into the prosthesis.

▪Rotate the inLink® tool anticlockwise until it

reaches the stop.

Do not rotate the key beyond the stop. Other-

wise, the wings on the lock will retract and the

lock will subsequently detach in the mouth.

▪Remove the inLink® tool.

▪Check that the lock is properly seated by press-

ing down on the head of the lock with the ball

wrench.

If the lock is not properly seated, it may detach

from the prosthesis in the paent’s mouth.

▪inLink® locks on carrier

▪Place the holder in the prosthesis.

▪Press down on the holder to insert the lock and

ring into the prosthesis.

▪Turn the holder anticlockwise until it reaches

the stop.

▪Using a ball wrench, press down on the lock to

ensure that the lock and ring are securely seated.

Step C4 (oponal): Try the inLink® prosthesis

Before screwing the prosthesis, ensure that the

Axiom® TL implants and/or the inLink® abutments are

free of any uid or other substance that may compro-

mise the proper t of the prosthec component on

the Axiom® TL implants and/or the inLink® abutments.

▪Assemble the try-in locks into the prosthesis (as

described in the Step C3)

▪Position the prosthesis equipped with try-in locks

in the mouth.

To facilitate inseron of the prosthesis, gradually

pre-ghten the locks in a criss-cross paern, start-

ing with the guiding locks.

▪Tighten the try-in inLink® locks to 25 N.cm with

the ball wrench and the prosthetic dynamometric

wrench or with the ball mandrel and the TORQ

CONTROL®.

▪Check that the platforms are properly contacting

and that each lock is fully tightened.

If in doubt, take retroalveolar radiographs perpen-

dicular to the connecons.

▪Unscrew the try-in locks

▪Disassemble the try-in locks of the prosthesis (as

described in the Step C6)

Step C5: Place the inLink® prosthesis onto the

implants/abutments

Before screwing the prosthesis, ensure that the

Axiom® TL implants and/or the inLink® abutments

are free of any uid or other substance that may

compromise the proper t of the prosthec compo -

nent on the Axiom® TL implants and/or the inLink®

abutments.

Over-ghtening the locks can deteriorate the implant

connecon and/or break the locks.

Insucient ghtening of the locks may result in the

prosthesis falling into the paent’s mouth.

▪

Clean and sterilise (See §Cleaning and disinfection

and §Sterilisation) the prosthesis.

▪Position the prosthesis equipped with definitive

locks in the mouth.

To facilitate inseron of the prosthesis, gradually

pre-ghten the locks in a criss-cross paern, start-

ing with the guiding locks.

▪

Tighten the definitive inLink® locks to 25 N.cm with

the ball wrench and the prosthetic dynamometric

wrench or with the ball mandrel and the TORQ

CONTROL®.

▪Check that the platforms are properly contacting

and that each lock is fully tightened.

If in doubt, take retroalveolar radiographs perpen-

dicular to the connecons.

▪Close up the screw channel with Teflon, then seal

with composite.

Step C6: Caring for the inLink® prosthesis

We recommend changing the locks every me the

prosthesis is demounted.

Final locks pre-mounted on holders are available to

facilitate inseron.

Step C7: Replacement of inLink® locks

Disassemble the inLink® locks:

▪Using the 2in1 inLink® tool

▪Use the “OUT” side of the inLink® tool.

▪Screw the lock into the inLink® tool by rotating

the ball wrench clockwise.

▪Remove the lock by turning the key clockwise

and pulling.

▪Unscrew the lock from the key using the ball

wrench.

en – Instructions for Use – Axiom® plural definitive abutments

5/6

▪Using the disassembly inLink® tool

▪Screw the lock into the inLink® tool by rotating

the ball wrench clockwise.

▪Remove the lock by turning the key clockwise

and pulling.

▪Unscrew the lock from the key using the ball

wrench.

Assemble news inLink® locks:

See the Step C3

D. Prosthec screw for customised

prosthesis

Over-ghtening the screw can deteriorate the abut-

ment connecon and/or break the screw.

Insucient ghtening of the screw may result in the

screw and/or the prosthesis falling into the paent ’s

mouth.

▪

Clean and sterilise (See §Cleaning and disinfection

and §Sterilisation) the prosthesis and the definitive

screw.

▪Before screwing the prosthesis, ensure that the

connection is free of any fluid or other substance

that may compromise the proper fit of the pros-

thetic component in the implant.

▪Place the prosthesis into the implant.

▪Tighten the definitive screw to 25 N.cm with the

hexagonal wrench and the prosthetic dynamomet-

ric wrench or with the hexagonal mandrel and the

TORQ CONTROL®.

▪Close the screw channel.

13. Healing phase

The healing period required for osseointegraon

varies considerably and depends on the individual

paent and treatment.

It is the sole responsibility of the surgeon to decide

when the implant can be loaded.

14. Further informaon

For more informaon on the use of Anthogyr prod-

ucts, please contact your local Anthogyr sales rep-

resentave or contact Anthogyr customer service

or visit ifu.anthogyr.com and www.anthogyr.com.

For more specic informaon on the Axiom® plural

denive abutments, please refer to:

▪

Axiom® Multi Level® Prosthetic user guide (AXIOM-

MLP_NOT)

▪

Customised prosthesis design user guide (MANUEL-

CAD_NOT)

Subject to the availability of the European Medical

Device Database (EUDAMED), the summary of safe-

ty and clinical performance characteriscs (SSCP)

is available at hps://ec.europa.eu/tools/eudamed.

Unl Eudamed is fully funconal, SSCP can be re-

quested to Anthogyr at the following address:

clinical@anthogyr.com.

Product Type Basic UDI-DI

Mul-Unit copings

CoCr coping 36633940019QX

PACIFIC Kit 36633940011QF

PACIFIC ring 36633940009QU

Product Type Basic UDI-DI

Prosthec screws DLC coated

prosthec screws 36633940010QD

inLink® locks DLC coated inLink®

locks 36633940023QN

inLink® locks inLink® locks 36633940022QL

Mul-Unit

protecve cap Protecve caps 36633940003QG

Mul-Unit

abutments

inLink® abutments

Sterile Titanium

abutment 36633940008QS

15. Storage

Store these products in a clean, dry area, at room

temperature. Improper storage may compromise the

essenal characteriscs of the materials and design,

which may lead to device failure.

16. Waste treatment

Waste resulng from the intervenon (packaging,

part extracted, etc.) must be handled as medical

waste under the responsibility of the user.

17. Paent informaon

Paents must accept regular medical follow-ups and

should consult their doctor in the event of any unex-

pected change in the performance of the prosthec

reconstuon.

Paents must be informed of the need to ensure

regular oral hygiene.

Paent must be advised to remain cauous for the

rst few weeks aer surgery.

Traceability informaon is available to paents via

the detachable labels on the device.

18. Notes

The praconer must have the necessary knowl-

edge to pracce dental implantology and must be

familiar with the handling instrucons for Anthogyr

products as described in this document in order to

use Anthogyr products safely and in accordance with

their instrucons for use.

Anthogyr products must be used in accordance with

the manufacturer’s instrucons for use. The dental

surgeon is solely responsible for the proper use of

Anthogyr products in accordance with their instruc-

ons for use and to determine whether the product

is suitable for the individual paent’s situaon.

Anthogyr products are part of a complete range and

must be used in combinaon with the corresponding

original components and instruments distributed by

Anthogyr, its parent company and any aliates or

subsidiaries of the parent company (“Straumann”).

The use of third-party products not distributed by

Anthogyr voids any warranty or other obligaon,

express or implied, of Anthogyr.

Any product-related issues must be reported to the

local Anthogyr organisaon together with the prod-

uct in queson. In the event of a serious incident,

the user must le a report with the local Anthogyr

organisaon and the appropriate competent authori-

ty in accordance with local regulaons. Anthogyr also

oers an online complaint service in the countries

concerned.

19. Validity

The publicaon of this document supersedes and

replaces all previous versions.

Anthogyr® and/or other trademarks and logos of

Anthogyr® menoned herein are trademarks or

registered trademarks of Anthogyr.

20. Availability

Some components of the Anthogyr implant system

are unavailable in certain countries.

21. Symbols

The following table describes the symbols that may

be printed on the packaging label. Please refer to

the label on the packaging for the applicable prod-

uct symbols.

Symbol Symbol Descripon Symbol Source

Manufacturer NF EN ISO 15223-1

Date of manufacture NF EN ISO 15223-1

Catalogue number NF EN ISO 15223-1

Batch code NF EN ISO 15223-1

Serial number NF EN ISO 15223-1

Consult instrucons for

use or consult electronic

instrucons for use

NF EN ISO 15223-1

Medical Device NF EN ISO 15223-1

CE marking - compliance

with current regulaons

Direcve

93/42/CEE

—

MDR (EU)

2017/745

FDA cercaon logo 21 CFR 801.109(b)

(1)

Use-by date NF EN ISO 15223-1

Single sterile barrier

system NF EN ISO 15223-1

Single sterile barrier

system with protecve

packaging inside

NF EN ISO 15223-1

Sterilized using irradiaon NF EN ISO 15223-1

Do not resterilise NF EN ISO 15223-1

Non-sterile NF EN ISO 15223-1

Sterilizable in a steam

sterilizer (autoclave) at

temperature specied

ISO 7000 - 2868

Non sterilizable in a steam

sterilizer (autoclave) at

temperature specied

Anthogyr

Do not use if packaging

is damaged and consult

instrucons for use

NF EN ISO 15223-1

Keep away from sunlight NF EN ISO 15223-1

en – Instructions for Use – Axiom® plural definitive abutments

6/6

Symbol Symbol Descripon Symbol Source

Do not re-use. NF EN ISO 15223-1

Cauon NF EN ISO 15223-1

fContains hazardous

substances NF EN ISO 15223-1

Screwing torque Anthogyr

Axiom® BL Mul-Unit

straight abutment Anthogyr

Axiom® BL Mul-Unit

angulated abutment +

prosthec screw

Anthogyr

Axiom® TL Mul-Unit

straight abutment Anthogyr

Axiom® BL InLink®

abutment Anthogyr

Axiom® Mul-Unit

protecve cap Anthogyr

Axiom® Mul-Unit CoCr

coping + prosthec screw Anthogyr

Axiom® Mul-Unit

castable coping +

prosthec screw

Anthogyr

Axiom® Mul-Unit PACIFIC

coping + prosthec screw Anthogyr

Axiom® M1.6 prosthec

screw Anthogyr

Mul-Unit M1.4 prosthec

screw Anthogyr

Axiom® TL standard

InLink® lock Anthogyr

Axiom® TL guiding InLink®

lock Anthogyr

Axiom® TL standard

InLink® lock with carrier Anthogyr

Axiom® TL guiding InLink®

lock with carrier Anthogyr