Anthogyr Mini Implant User manual

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en - Instrucon for use - Anthogyr Mini Implant

A Anthogyr

2237 Av. André Lasquin

74700 Sallanches – France

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

www.anthogyr.com

Email : [email protected]

Validity Date : 2021-03

REF : 063IMPL-MIO_NOT

Index : A

1. Product descripon

Anthogyr Mini Implant is a single-component

implant with an Oploc® prosthec connecon.

The Anthogyr Mini Implant system includes ins-

truments and prosthec and surgical parts.

Anthogyr Mini Implants are implants with a

sandblasted BCP bone anchoring surface and a

DLC (a-C:H) coated connecon.

The Oploc® matrix system is a prefab connetor

for the retenon of removable restoraons on

Anthogyr Mini Implants. The Oploc® matrix is

made of a housing and interchangeable plasc

(PEEK) retenon inserts with dierent colour-

coded retenon values or extracon forces.

These instrucons for use are valid for the follo-

wing dental implants:

- Anthogyr Mini Implants

Materials:

Titanium-6aluminium-4vanadium alloy:

2. Intended use

Anthogyr Mini Implants are intended for the

replacement of missing tooth roots and allows

the stabilisaon of removable full dentures.

3. Indicaons

Anthogyr Mini Implants are indicated for the

stabilisaon of complete removable dentures in

the mandible and/or maxilla with a total eden-

tulousness.

They allow immediate loading in an appropriate

clinical situaon (good primary stability).

4. Clinical benets

- Stabilisaon of removable prosthesis

- Restoraon of mascatory funcon

- Aesthec restoraon

5. Paent type and intended user

Anthogyr Mini Implants are intended for use

with parally or totally edentulous adult pa-

ents who do not present any of the condions

menonned in the “contraindicaons”secon.

Anthogyr Mini Implants must be used by a sur-

geon trained in dental implantology.

6. Contraindicaons

Anthogyr Mini Implants are contraindicated in

following cases:

- Implant divergence greater than 40° between

two implants.

- D4 bones .

- Allergy or hypersensivity to chemical com-

ponents in the materials used and menoned in

the “Product descripon” secon.

- Absolute contraindicaons: serious diseases

(tumours, heart disease, etc.), metabolism disor-

ders, uncompensated haematologic diseases,

drug addion, alcoholism, psychosis, funconal

disorders, xerostomia, immune deciency, leu-

kocyte disorder, local or systemic treatments

(steroid, ancoagulant, chemotherapy or radia-

on therapy, etc.).

- Relave contraindicaons: bruxism, occlusal

stress, parafuncon, unfavourable bone anato-

my, pregnancy, growth not nished, insucient

oral hygiene, smoking lack of movaon or

cooperaon, irradiated bone, uncontrolled pe-

riodontal disease, oral infecons or inamma-

ons.

- Localised contraindicaons: Excessive resorp-

on and/or insucient bone quality, local radi-

cular residues.

7. Warning

Implant surgery is a complex dental procedure.

Incorrect 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 oers

specic training.

8. Cauon/precauons

Clinical use:

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

Risk of contaminaon and risk of alteraon of

the funconal surfaces.

It is important to perform a pre-clinical as-

sessment and treatment plan that takes into

account the anatomical constraints of the future

restoraon.

Do not use an implant aer the expiry date indi-

cated on the packaging

Safety informaon regarding magnec re-

sonance 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) envi-

ronment. They have not been tested for heat

build-up, migraon or artefacts in MR environ-

ments. 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 injuries.

9. Unwanted side eects

The clinical outcome of dental treatment is in-

uenced by mulple factors. The following resi-

dual risks and possible side eects are related to

the use of Anthogyr Mini Implant and may lead

to addional dental treatment at the dental

pracce: swelling, haematoma, risk of swallo-

wing/inhaling small parts during the procedure,

phonec problems, pain, hypersensivity/

allergic reacons, inadequate funcon or device

failure (mobility, loss of integrity), aesthec

problems, gingival injuries, damage to exisng

denon, bone damage, loss of marginal bone,

hyperplasia, exfoliaon, dysesthesia, post-

surgical paraesthesia, perforaon of sinus or

alveolar plates, systemic or local infecon

(including peri-implans, periodons, gingivi-

s, stula), local or systemic infecons including

bacterial endocardis.

10. Compability informaon

Anthogyr Mini Implants must be used in combi-

naon with the corresponding Oploc® system

components and Oploc® compable over-

dentures.

Only use original parts with the Oploc® connec-

on to place Anthogyr Mini Implants. If unsui-

table ancillary equipment is used: risk of injury,

damage and malfuncon of the implant, risk of

damage to the ancillary equipment.

For more informaon, please refer to the ma-

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

11. Cleaning and disinfecon

Anthogyr Mini Implants are supplied sterile

(GAMMA sterilisaon) and are intended for

single use. Do not clean or sterilise the implants.

Cleaning, disinfecon and sterilisaon can com-

promise the essenal material and design fea-

tures of the implants and result in device failure.

12. Sterilisaon

Anthogyr dental implants are supplied sterile.

Check that the enre packaging of the device is

undamaged before opening. Implant with a da-

maged packaging must not be used. It is recom-

mended to have a replacement implant readily

available for use. The intact blister pack protects

the sterilised implant against any external in-

uence and, if stored properly, guarantees steri-

lity unl the expiry date. The blister pack must

not be opened before implant use. When remo-

ving the implant from the sterile packaging,

asepsis rules must be followed.

Anthogyr declines all responsibility for re-

sterilised implants, regardless of who carried out

the re-sterilisaon or the method used. Under

no circumstances should a previously used or

Chemical components Composion, %

(mass/mass)

Aluminium 5.50 to 6.50

Vanadium 3.50 to 4.50

Other (Fe, O, C, N, H) Total max 0.53

Titanium Balance

Type of

implant

Type of

connecon

Compable

components

Anthogyr Mini

implant Oploc® Oploc®

Compable instruments

Oploc® screwing instruments included in the

kit.

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en - Instrucon for use - Anthogyr Mini Implant

unsterile implant be implanted. If the original

packaging is damaged, Anthogyr will not accept

the return of the content.

13. Protocol for use

Refer to the brochures listed in the “Further

informaon” secon for detailed step-by-step

instrucons.

Step 1 : Preoperave planning

The length of the implant, as well as the number

of implants to be used and their posioning,

must be determined in advance, taking into

account the paent’s anatomy and the oral envi-

ronment. For this purpose, use the X-ray tem-

plates available for the range.

A sucient number of implants must be used to

provide support and distribute the support

loads:

→ A minimum of 4 mini implants Ø2.6 must be

placed for mandibular restoraons.

→ A minimum de 6 mini implants Ø2.6 must be

placed for maxillary restoraons.

Step 2 : Implant bed preparaon

→ Mark the site with a pointer drill.

→ Each site should be prepared using a progres-

sive sequence of drilling diameters in accor-

dance the bone density. Make sure never to

exceed the depth of the planned drilling: pre-

sence of depth marks on each rotang instru-

ment or use of drills with a stop or a contra-

angle ed with a stop system.

Please refer to the “step-by-step” guidelines

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

Avoid overheang the bone when drilling and

ghtening the implant to reduce the risk of bone

loss during the osteointegraon phase. The risk

of overheang the bone can be reduced by using

irrigaon and by controlling the torque.

Step 3 : Removing the implant from the packag-

ing

The Anthogyr Mini Implant is packaged in a card-

board box with sterile packaging consisng of a

sealed blister pack and a capped tube. They are

delivered mounted in the cap which serves as an

implant holder.

→ Remove the blister from the cardboard box

outside of the sterile eld.

→ Open the seal without touching the inside of

the blister.

→ Let the capped tube gently fall on the sterile

eld.

Warning: Do not use an Anthogyr Mini Implant if

it is detached from the cap aer opening the

blister.

Warning: All handling should be done so as to

avoid direct contact with the exterior surface of

the implant. When handling the implant, be very

careful not to drop it in the paent’s mouth.

Make sure that the implant does not touch the

tube.

Step 4 : Inserng the implant

PRE-SCREWING THE IMPLANT :

Pre-screwing of the implant should be done

manually using the packaging cap unl more

torque is required.

PLACEMENT USING A CONTRA-ANGLE:

→ Adjust the output speed of the contra-angle

to the recommended speed of 15 rpm.

→ Using the contra-angle and the Oploc®

adapter, screw the implant into the channel to

the desired depth. The implant must be placed

so that the Oploc® connector is above the gum.

Warning: Check the ghtening torque frequently

to make sure it does not exceed 45 N.cm. Un-

ghten and reghen to reduce the screw pres-

sure if needed.

MANUAL PLACEMENT:

Using the ratchet wrench (available in the kit):

→ Assemble the Oploc® key adapter and the

surgical ratchet wrench

→ Screw the implant into the channel to the

desired depth. The implant must be placed so

that the Oploc® connector is above the gum.

Warning: When inserng the implant with the

surgical ratchet wrench control of the ghtening

torque is not possible. However, the vericaon

of the torque using a surgical dynamometric

wrench to ghen the implant is possible.

A torque too high can damage the connecon.

Unghten and reghen to reduce the screw

pressure if needed.

Step 5 : Fabricaon of the prosthesis

The prosthesis must be fabricated according to

the prosthec techniques of removable restora-

on on mini implants.

For immediate loading, a minimum inseron

torque of 35 N.cm is recommended.

Abnormal loading of the implant may result in

implant fracture.

For more informaon on the prosthec

procedure, please refer to the "Further Informa-

on" secon.

Step 6 : Maintenance

MAINTENANCE BY THE CLINICIAN:

During periodic visits, please inspect the condi-

on of each secondary part of the denture re-

tenon system. Always use plasc instruments

during the visit. The proper seang of the pros-

thesis on the mucosa should be checked at least

once a year and, if necessary, the prosthesis

should be relined to avoid abnormal stress on

the implant structure.

MAINTENANCE BY THE PATIENT:

(please pass on the following informaon to the

paent):

The paent's aenon should be drawn to the

need for regular oral hygiene as well as the need

to thoroughly clean the Oploc® connecon of

the Mini Implants every day.

14. Healing phase

The healing period required for osseointegraon

varies considerably and depends on the indivi-

dual paent and treatment.

It is the sole responsibility of the surgeon to

decide when the implant can be loaded. If tem-

porary components are used during the healing

phase, they must be placed in sub-occlusion.

15. Further informaon

For more informaon on the use of Anthogyr

products, please contact your local Anthogyr

sales representave or contact Anthogyr custo-

mer service or visit ifu.anthogyr.com and

www.anthogyr.com.

For more specic informaon on Anthogyr Mini

Implants, please refer to :

- Anthogyr Mini Implants User Guide

(MIO_NOT)

- Mini Implant System Catalog (C210)

- Mini Implant System Leaet (C211)

Subject to the availability of the European Medi-

cal Device Database (EUDAMED), the summary

of safety and clinical performance characteriscs

(SSCP) is available at hps://ec.europa.eu/tools/

eudamed.

16. Storage

Store these products in a clean, dry area, at

room temperature. Improper storage may com-

promise the essenal characteriscs of the ma-

terials and design, which may lead to device

failure.

17. Waste treatment

Waste resulng from the intervenon

(packaging, part extracted, etc.) must be han-

dled 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 unexpected 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

knowledge to pracce dental implantology and

must be familiar with the handling instrucons

for Anthogyr products as described in this docu-

ment 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 pro-

per use of Anthogyr products in accordance with

their instrucons for use and to determine whe-

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ther 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 cor-

responding original components and instru-

ments distributed by Anthogyr, its parent com-

pany and any aliates or subsidiaries of the

parent company (“Straumann”), unless other-

wise specied in these instrucons for use. 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 product 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 authority in accordance with local

regulaons. Anthogyr also oers an online com-

plaint 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 sys-

tem 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 appli-

cable product symbols.

Symbol Descripon of symbol Source of

symbol

A Manufacturer ISO 15223-1

B Date of manufacture ISO 15223-1

N Catalog number ISO 15223-1

O Batch code ISO 15223-1

P Serial number ISO 15223-1

Consult the instrucons for

use or consult the digital

instrucons for use

ISO 15223-1

b Medical Device PR 15223-1

(2020)

e Unique idener of the

device

PR 15223-1

(2020)

G CE marking - compliance

with current regulaons

Direcve

93/42/CEE

——————

MDR (EU)

2017/745

i GOST-R logo for cercaon

of the Russian Federaon

]only FDA cercaon logo

21 CFR

801.109(b)

(1)

V Use-by date ISO 15223-1

c Single sterile barrier system ISO 7000

a Single sterile barrier system

with protecve packaging

inside

ISO 7000

S Sterilized using irradiaon ISO 15223-1

? Do not resterilise ISO 15223-1

F Non-sterile ISO 15223-1

Suitable for sterilisaon in a

steam steriliser (autoclave)

at the specied temperature

(135°C)

ISO 7000 -

2868

Non suitable for sterilisaon

in a steam steriliser

(autoclave) at the specied

temperature (135°C)

Anthogyr

X Do not use if packaging is

damaged or consult instruc-

ons for use

ISO 15223-1

Y Keep away from sunlight ISO 15223-1

W Do not reuse ISO 15223-1

E Warning ISO 15223-1

f Contains hazardous subs-

tances ISO 7000

Anthogyr Mini Implant User manual

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