Anthogyr 0459 User manual

1/4

en – Instructions for Use – Axiom® definitive abutments

0459

Anthogyr

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 : 2022-02

REF: 063PROTH-UNIT_NOT

Index: B

Axiom® denive abutments

Instrucons for Use

Aesthec impacted

abutments

Aesthec abutments Straight standard

abutments

Angulated standard

abutments

Try-in abutments Castable copings Protecon caps Prosthec screw for

customized prosthesis

Axiom® 2.8 Axiom® BL Axiom® BL

Axiom® 2.8 Axiom® TL

1. Product descripon

The Axiom® denive abutments range includes de-

nive abutments, try-in abutments, protecon caps

and castable copings.

These instrucons for use are valid for the following

Axiom® components:

▪Aesthetic impacted abutments

▪Aesthetic abutments

▪Straight standard abutments

▪Angulated standard abutments

▪Try-in abutments

▪Protection caps

▪Castable copings

▪Prosthetic screw for customized prosthesis

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

ic abutments, Straight standard abutments and An-

gulated standard abutments, in the same packaging.

Materials:

Aesthec impacted abutments, Aesthec abutments,

Straight standard abutments,Angulated standard

abutments and screws are made of Titanium-6Alu-

minium-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

Protecon caps are made of Polyetheretherketone

(PEEK):

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

Polyetheretherketone 100

Try-in abutments are made of Titanium (Ti6Al4V ELI).

Castable copings are made of Polymethylmethacry-

late (PMMA).

2. Intended use

Axiom® denive abutments are intended to be

placed into Axiom® dental implants to provide sup-

port for cemented restoraons aer oral implanta-

on.

Prosthec screws for customized prosthesis are in-

tended to be placed into Axiom® TL dental implants

to provide support for screw retain customized res-

toraons aer oral implantaon.

Try-in abutments are intended to be temporarily po-

sioned in dental implants to represent the denive

abutment geometry aer oral implantaon.

Protecon caps are intended to protect the coronary

part of abutments during the healing phase aer oral

implantaon.

Castable copings are intended to be cast in a metal

par t to produce a restoraon adapted to the coronary

parts of abutments aer oral implantaon.

3. Indicaons

Aesthec impacted abutments are indicated to sup-

port denive single-unit cemented restoraons on

Axiom® 2.8 dental implants.

Aesthec abutments are indicated to support de-

nive single-unit or mulple-unit cemented resto-

raons on Axiom® BL dental implants.

Straight standard abutments are indicated to support

denive single-unit or mulple-unit cemented res-

toraons on Axiom® BL dental implants.

Angulated standard abutments are indicated to sup-

port denive mulple-unit cemented restoraons

on Axiom® BL dental implants.

Standard abutments can be used at the me of im-

plant placement.

Prosthec screws for customized prosthesis are in-

dicated to support customized denive single-unit

screw retain restoraons on A xiom L dental implants.

Protecon caps are indicated to protect the coronary

part of the abutment during healing process with

abutment in place. Protecon caps have a maximum

duraon of usage of 180 days.

Indicaon

Single-unit Mulple-unit

Axiom® BL

Aesthec abutments • •

Straight standard abutments • •

Angulated standard abutments •

Axiom® 2.8

Aesthec impacted abutments •

Axiom® TL

Prosthec screws for

customized prosthesis •

4. Paent type and intended user

Aesthec impacted abutments, Aesthec abutments,

Straight standard abutments, Angulated standard

abutments, Protecon caps, Castable coping, try-

ing abutments and screws are intended for adults

requiring a single-unit and/or mulple-unit tooth

restoraon and who do not present any of the con-

dions menoned in the "Contraindicaons" secon.

These components must be placed 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.

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

products are required. Anthogyr offers specific

training.

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.

en – Instructions for Use – Axiom® definitive abutments

2/4

▪It is important to perform a pre-clinical assess-

ment and treatment plan that takes into account

the anatomical constraints of the future resto-

ration.

▪The definitive prosthetic component must be

fixed on a sufficiently stable implant.

▪As far as possible, the prosthetic components

must be firmly fastened to avoid the inhalation

or swallowing of components during intraoral use.

▪

The prosthetic components must not be tightened

with a contra-angle.

▪

Do not use a prosthetic part after the expiry date

indicated on the packaging.

Component rework:

Aesthec impacted abutments can be reworked only

in the coronar y poron in case where the impression

is taken at the implant level.

Aesthec abutments can be reworked only in the

coronary poron.

Other components must not be reworked. The

emergence prole must not be altered in order to

maintain the original smooth surface.

Improper modicaon can induce mechanical weak-

ening.

Safety informaon regarding magnec

resonance imaging (MRI):

The safet y and compability of Anthogyr devices that

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

ated 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

Anthogyr devices in an MR environment is unknown.

Performing 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 Axiom® denive abut-

ments, Protecon caps, Try-in abutments, Castable

copings, Castable coping, trying abutments 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

Anthogyr implants and prosthec components are

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

Anthogyr parts 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.

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 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 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 sterilisa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.

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 circum-

stances should a previously used or non-sterile pros-

thec component be placed in the paent's mouth.

Compable informaon table

IMPLANT ABUTMENT SECONDARY PART SCREW

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

instrument

Compable castable

copping

Compable

protecon cap

Screw reference Compable

instrument

Axiom® 2.8 Conical Aesthec impacted

abutments

Prehensive wrench

(OPOP028)

AND

Impacon p + SAFE

LOCK®

OPPC028 OPCA028 - -

Axiom® BL Conical

Aesthec abutments

Axiom® BL abutment

gripper

(INEXPS/I NEXPL)

- -

OPTS160

Hexagonal instruments

Straight standard

abutments

OPCA30X

OPCA40X

OPCA50X

OPCA60X

OPCR30X

OPCR40X

OPCR50X

OPCR60X

OPPC30X

OPPC40X

OPPC60X

Angulated standard

abutments

OPCR30X

OPCR40X

OPCR50X

OPCR60X

Axiom® TL Indexed M1.6

connecon (at)

Simeda® customized

abutment - - - TS160

en – Instructions for Use – Axiom® definitive abutments

3/4

If the original packaging is damaged, Anthogyr will

not accept the return of the content.

Non-sterile components:

Anthogyr prosthetic 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.

Axiom® 2.8

Step 1: Choose the right abutment

▪

Clean and sterilise (See Cleaning and disinfection

and Sterilisation) the try-in abutments.

▪Use the prehensive wrench for try-in abutment

installation in mouth:

Insert the abutment in the wrench aligning the

arrow marked on the wrench with the flat ledge

of the abutment.

2. Place the abutment into the implant:

▪To place the flat spot in the vestibular area,

use the arrow to identify the flat spot.

▪

To place the flat spot in the lingual area, use

the point (located at 180° of the arrow) to

identify the flat spot (if not visible in the

mouth).

3. Press the button on the wrench to release the

abutment.

▪

Place and remove different try-in abutments into

the implant to find the most suitable one.

▪Choose the reference of the impacted abutment

according to the try-in abutment selected.

Step 2: Place the aesthec impacted abutment

▪

Remove the abutment from the sterile packaging

on the sterile field.

▪

Before placing the abutment, ensure that the con-

nection is free of any fluid or other substance that

may compromise the proper fit of the prosthetic

component in the implant.

▪Using the prehensive wrench, secure the abut-

ment before transporting it in the patient mouth:

follow the same steps as in “Step 1: Choose the

right abutment”.

▪Before impaction of the definitive restoration

in mouth, make a local anaesthesia if necessary.

▪Select the impaction tip which is adapted to the

abutment:

▪

In case of installation of a prosthesis cemented

inside of the mouth, use one of the 2 adapted

impaction tips, depending on the angulation of

the abutment. For 15 and 23° angulated abut-

ments, position the laser marking of the tip on

the flat surface of the abutment.

▪

In case of installation of a prosthesis cemented

outside of the mouth, use the impaction tip

adapted to the incisors to secure the prosthesis

in the implant. For effective transmission of the

impaction force, place the impaction tip firmly

against the incisor edge of the prosthesis and

as close to the implant axis as possible.

▪Position the flat ledge of the abutment in the

vestibule (or in the lingual surface in the case of

straight abutments) using the prehensive wrench.

▪

Tighten the impaction tip on the SAFE LOCK®, ad-

just the motor speed to 10 000 rpm maximum.

Position the tip on the abutment or the prosthesis

before pressing the pedal and wait for 5 strokes.

Step 3: Protect the abutment during healing

phase

▪

Clean and sterilise (See Cleaning and disinfection

and Sterilisation) the protection cap.

▪Clean the abutment ’s coronary part thoroughly.

▪Seal the protection cap onto the abutment using

temporary cement.

Step 4: Place the crown onto the abutment

▪Use the castable coping as support for making

the wax crown on the master model.

▪Make the metallic crown according to current

casting and finishing protocols.

▪Remove the protection cap.

▪Cement the crown onto the abutment.

Axiom® BL

Choose the right abutment

▪

Clean and sterilise (See Cleaning and disinfection

and Sterilisation) the try-in abutments.

▪Secure the try-in abutments before transporting

it in the patient mouth.

▪

Place and remove different try-in abutments into

the implant to find the most suitable one.

▪Choose the reference of the definitive abutment

according to the try-in abutment selected.

A. Protocol for aesthec abutments

▪

Clean and sterilise (See Cleaning and disinfection

and Sterilisation) the abutment and the definitive

screw.

▪Before screwing the abutment, 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 abutment into the implant with Axiom®

BL abutment gripper if needed.

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

hexagonal wrench and the prosthetic dynamo-

metric wrench or with the hexagonal mandrel and

the TORQ CONTROL®.

▪Close the screw channel.

▪Cement the restoration onto the abutment.

B. Protocol for straight and angulated standard

abutments

Step B1: Place the standard abutment

▪Before screwing the abutment, 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 abutment into the implant with Axiom®

BL abutment gripper if needed.

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

hexagonal wrench and the prosthetic dynamo-

metric wrench or with the hexagonal mandrel and

the TORQ CONTROL®.

▪Close the screw channel.

Step B2: Protect the standard abutment during

healing phase

▪

Clean and sterilise (See Cleaning and disinfection

and Sterilisation) the protection cap.

▪Clean the abutment’s coronary part thoroughly.

▪Seal the protection cap onto the abutment’s cor-

onary part using temporary cement.

Step B3: Place the restoraon onto the standard

abutment

▪

Use the castable coping as support for making the

wax restoration on the master model:

▪Use indexed castable coping for single-unit res-

toration.

▪

Use non-indexed castable coping for multiple-unit

restoration.

▪Make the metallic restoration according to cur-

rent casting and finishing protocols.

▪Remove the protection cap.

▪Cement the restoration onto the abutment.

Axiom® TL

▪

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 dynamo-

metric wrench or with the hexagonal mandrel and

the TORQ CONTROL®.

▪Close the screw channel.

13. Healing phase

The protecon caps must be placed in sub-occlusion.

14. Lifespan of products

The Try-in abutments can be reused during 5 years,

except in cases where there are signs of deterio-

raon (illegibility of markings or markers, signs of

corrosion, etc.).

Other components are for single-use.

15. 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® den-

ive abutments, please refer to:

en – Instructions for Use – Axiom® definitive abutments

4/4

▪Axiom® 2.8 user guide (AXIOM2-8_NOT)

▪Axiom® Multi Level® Prosthetic user guide

(AXIOM-MLP_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, the SSCP can be

requested to Anthogyr at the following address:

clinical@anthogyr.com.

Product Type Basic UDI-DI

Sterile Titanium abutment 36633940008QS

Non-sterile Titanium abutment 36633940009QU

Protecve cap 36633940006QN

DLC coated prosthec screw 36633940010QD

16. 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.

17. 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.

18. 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.

19. 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.

20. 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.

21. Availability

Some components of the Anthogyr implant system

are unavailable in certain countries.

22. 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 Descripon of symbol Source of symbol

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

Sterilised using

irradiaon NF EN ISO 15223-1

Do not resterilise NF EN ISO 15223-1

Non-sterile NF EN ISO 15223-1

Sterilisable in a steam

steriliser (autoclave) at

temperature specied

ISO 7000 - 2868

Non sterilisable in

a steam steriliser

(autoclave) at

temperature specied

Anthogyr

Do not use if packaging

is damaged and

consult instrucons

for use

NF EN ISO 15223-1

Symbol Descripon of symbol Source of symbol

Keep away from

sunlight NF EN ISO 15223-1

Do not re-use NF EN ISO 15223-1

Cauon NF EN ISO 15223-1

Contains hazardous

substances NF EN ISO 15223-1

Screwing torque Anthogyr

Axiom® 2.8 straight

impacted abutment Anthogyr

Axiom® 2.8 angulated

impacted abutment Anthogyr

Axiom® BL straight

aesthec abutment +

prosthec screw

Anthogyr

Axiom® BL angulated

aesthec abutment +

prosthec screw

Anthogyr

Axiom® BL straight

standard abutment +

prosthec screw

Anthogyr

Axiom® BL angulated

standard abutment +

prosthec screw

Anthogyr

Axiom® protecve cap Anthogyr

Axiom® M1.6

prosthec screw Anthogyr

Anthogyr 0459 User manual

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