Anthogyr Axiom Plural Definitive Abutments Instructions

: June 9, 2024
: Anthogyr

Axiom® plural definitive abutments
Instructions for Use

Axiom Plural Definitive Abutments

Multi-Unit abutments| Multi-Unit protective caps| Multi-Unit copings| InLink® abutments| InLink® Try-in locks| lock for inLink® prosthesis Definitive inLink®Definitive inLink® locks locks on carrier Axiom® TL inLink® abutments| Prosthetic screws for customized prosthesis Axiom® TL Multi-Unit abutments
---|---|---|---|---|---|---
Axiom® BL| Axiom® TL| Multi-Unit abutments| Axiom® BL

__

|

__

| | | | | | |

Product description

The Axiom® plural abutments range includes definitive abutments, castable copings, locks and screws. It also includes temporary components required for definitive restoration: protective cap & try-in locks. The instructions 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 definitive prosthetic screw is supplied with angulated Multi-Unit abutment and Multi-Unit copings, in the same packaging.
Materials:
Multi-Unit abutments, Multi-Unit protective cap, Titanium Multi-Unit copings, inLink® abutments, inLink® locks and screws are made of Titanium-6Aluminium- 4Vanadium
ELI alloy:

Chemical components	Composition, % (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

Definitive prosthetic screws and inLink® locks areDLC (Diamond Like Carbon) coated.
CoCr Multi-Unit copings are made of Cobalt-Chromium alloy (CoCr28Mo):

Chemical components	Composition, % (mass/mass)
Chromium	28.00 ± 2.00
Molybdenum	6.00 ± 1.00
Iron	≤ 0.75
Manganese	≤ 1.0
Silicon	≤ 1.0
Carbon	≤ 0.14
Nickel	≤ 1.00
Nitrogen	≤ 0.25
Cobalt	Balance

Specification about the melting range: 1390°C to 1415°C CoCr Multi -Unit copings also include a castable part made of Polymethyl methacrylate (PMMA).
inLink® locks on carrier are also made of Polyetheretherketone (PEEK):

Chemical components	Composition, % (mass/mass)
Polyetheretherketone	100

Castable Multi-Unit copings are made of Polymethyl methacrylate (PMMA)

Intended use

Multi -Unit abutments are intended to be placed into Axiom® implants to provide support for screw-retained restorations after oral implantation.
inLink® abutments include an inLink® connection and are intended to be placed into Axiom® BL implants to provide support for inLink® screw-retained restorations after
oral implantation.
Multi-Unit copings are intended to support the res- toration and fit the coronary parts of the Multi-Unit abutments after oral implantation.
Multi-Unit protective caps are intended to protect the coronary part of the Multi-Unit abutment after oral implantation and maintain, stabilise and form the soft tissue during the healing phase.
InLink® locks are intended to be placed into Axiom® TL implants or inLink® abutments to provide support for inLink® screw-retained restorations after oral implantation. Prosthetic screws for customized prostheses are intended to be placed into Axiom® TL dental implants or Multi -Unit abutments to screw- retain the customized restoration after oral implantation.

Indications

Multi-Unit abutments are indicated to support definitive multiple-unit screw- retained restorations on Axiom® BL and/or Axiom® TL dental implants. InLink® abutments are indicated to support definitive full-arch screw-retained restoration on Axiom® BL and/or Axiom® TL dental implants.
Multi -Unit copings are indicated to be part of a mul-tiple-unit restorati on and fi t this restorati on onto the coronary parts of the Multi-Unit abutments.
Multi-Unit protective caps are indicated to be placed after Multi-Unit abutments placement. Multi-Unit protective caps protect the coronary parts of the Multi-Unit abutments and maintain, stabilise and form the soft tissue during the healing phase. They have a maximum duration of usage of 180 days.
InLink® locks are indicated to support inLink® definitive full-arch screw- retained restorations on the assembly of Axiom® BL dental implants & inLink abutments 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 patient mouth after oral implantation.
Prosthetic screws for customized prostheses are indicated to screw-retain definitive customized multiple-unit restorations on Axiom® TL dental implants or Multi-Unit abutments.
Indication Multiple-unit Complet

Axiom® BL

Multi-Unit abutments| •| •
Multi-Unit copings| •| •
inLink• abutments| | •
Axiom® TL
Multi-Unit abutments| •| •
Multi-Unit copings| •| •
inLink locks| | •
Prosthetic screws for customized prosthesis| •| •

Patient type and intended user

Multi-Unit abutments, Multi-Unit copings, inLink® abutments, locks and screws are intended for adults requiring a multiple-unit or full arch tooth restorati on and who do not present any of the conditi ons mentioned in the “Contraindications” section. The prosthesis must be used by a surgeon trained in dental implantology.

Contraindications

Allergy or hypersensitivity to chemical components in the materials used and menti oned in the “Product description” section. Multi-Unit abutments must not be used for unitary restorati on and/or if the implant divergence is greater than 40° between two implants: risk of impossible insertion of the prosthesis. Axiom BL straight MU abutment Ø4.0 H0.75 is contraindicated for placement in positions 3,4,5,6,7 and 8. InLink® abutments must not be used for unitary restoration or partial restoration or implant-supported overdenture with a prefabricated bar attachment system.

Warning

Implant surgery is a complex dental procedure. Incorrect techniques can cause implant failure and/or loss of bone support. Appropriate training and qualification and a good knowledge of surgical techniques with Anthogyr products are required. Anthogyr offers specific training.Multi -Unit copings contain Cobalt. Cobalt is classified as a hazardous substance. Anthogyr has conducted a benefit-risk assessment on Cobalt contained in Anthogyr CoCr alloy. The overall conclusion of this assessment is that the Anthogyr material is safe, provided that the amount of restorations placed into a patient does not exceed 13 units. However, in the interest of your patient please consider alternative solutions.

Caution / Precaution 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 swallowing 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: Multi-Unit copings:
Castable coping: screw channel (up to the screw head) can be reworked.
CoCr coping: only the castable part can be reworked. 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 reworked. The other components must not be reworked in any way.

Safety information regarding magnetic resonance imaging (MRI): The safety and compati bility of Anthogyr devices that remain in the patient’s body have not been evaluated in the magnetic resonance (MR) environment. They have not been tested for heat build-up, migration or artefacts in MR environments. The safety of Anthogyr devices in an MR environment is unknown. Performing an MRI examinati on on a patient wearing such a device may result in injury.

Residuals risks and side effects

The clinical outcome of dental treatment is influenced by multiple factors. The following residual risks and possible side effects are related to the use of Multi-Unit abutments, Multi-Unit copings, inLink® abutments, locks and screws and may lead to additional dental treatment at the dental practice:

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-implantitis, 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 effects:

swelling
local inflammation
bruising
resorption of maxillary/mandibular ridge bone
local infection
minor bleeding

Compatibility information

IMPLANT Type of implant Type of connection| ABUTMENT Type of abutment Compatible instruments| SECONDARY PART Compatible secondary parts| SCREW Screw reference Compatible instruments
---|---|---|---
Axiom® BL| Conical| Multi-Unit abutments| Multi-Unit screwing instruments| Multi-Unit protective caps| –| ****

Hexagonal instruments

Anthogyr implants and prosthetic components are available in a wide variety of configurations. Only Anthogyr parts that are compati ble with the implant connection are suitable for use. For more information, please refer to the manuals listed in the “Further information” section. An Axiom® BL implant can be made compatible with an Axiom® TL implant through the use of an InLink® abutment. CoCr casting alloy used must always have a lower melting point than the CoCr used for the CoCr coping.

Cleaning and disinfection Sterile components:

Anthogyr sterile prosthetic components are supplied sterile (GAMMA sterilisation) in blue packaging and are identified with a S logo. They are intended for single use. Do not clean or sterilise the prosthetic components. Cleaning, disinfection and sterilisation can compromise the essential material and design features of the prosthetic components and result in device failure.
Non-sterile components: Anthogyr non-sterile prosthetic components aresupplied in white packaging and are identified with a F logo. Before treatment, remove the components from their packaging. Do not use the components if the packaging is opened or damaged. Theymust be cleaned and decontaminated before use andafter each use for reusable components. Anthogyr recommends following the protocol described in the“cleaning and sterilization” manual available at ifu. anthogyr.com or on request from Anthogyr at theabove address. For sterilisation, see the “Sterilisation” section.
Specific CoCr copings cleaning: For the CoCr copings, please use the manual cleaning protocol as described in the “cleaning and sterilization” manual available at ifu.anthogyr.com or on request from Anthogyr at the above address.

Sterilisation Sterile components:

For sterile prosthetic components, check that the entire packaging of the device is undamaged before opening. Prosthetic 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 prosthetic component against any external influence and, if stored properly, guarantees sterility until the expiry date. The blister pack must not be opened before use of the prosthetic component. When removing the prosthetic 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-sterilisation or the method used. Under no circumstances should a previously used or non-sterile prosthetic component be placed in the patient’s mouth. 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 sterilisation manual available at ifu.anthogyr.com or on request from Anthogyr at the above address. After the sterilisation was done, asepsis rules must be followed.

Protocol for use

Refer to the brochures listed in the “Further information” section for detailed step-by-step instructions.
A. Multi-unit Step A1: Place the Multi-Unit 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 prosthetic component in the implant. Ensure that the Multi-Unit pre-assembled gripper is correctly placed on the Multi -Unit abutment before placing it in the mouth. If the mouth opening is narrow, remove the pre-assembled gripper from the Multi-Unit abutment and use the short gripper instead. Over-tightening the abutment can deteriorate the implant connection and/or break the abutment. Insufficient tightening of the abutment may result in the abutment falling into the patient’s mouth.

Straight Multi-Unit abutment
Pre-screw the Multi-Unit abutment into the implant with the gripper.
Remove the gripper from the Multi-Unit abutment.
Tighten the Multi-Unit abutment to 25 N.cm with the Multi-Unit wrench and the prosthetic dynamometric 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 abutment.

Step A2: Protect the Multi-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 construction (dental laboratory)
To perform the prosthesis work, use the laboratory screws and keep definitive screws for clinical use.
Build the definitive 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 current 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 current 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 current 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 Multi-Unit abutments
Before screwing the prosthesis, ensure that the Multi-Unit abutments are free of any fluid or other substance that may compromise the proper fit of the prosthetic component on the Multi -Unit abutments. Over-tightening the screw can deteriorate the abutment connection and/or break the screw. Insufficientti ghtening of the screw may result in the screw and/or the prosthesis falling into the patient’s mouth.

Prosthesis with straight screw channels
▪ Clean and sterilise (See §Cleaning and disinfec- tion and §Sterilisation) the prosthesis and definitive 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 disinfection and §Sterilisation) the prosthesis and definitive M1.4 AA screws.
▪ Position the prosthesis in the mouth.
▪ Tighten the definitive M1.4 AA screws to 15 N.cm with the ball wrench and the prosthetic dynamometric 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 connection is free of any fluid or other substance that may compromise the proper fit of the prosthetic component in the implant. Over-tightening the abutment can deteriorate the implant connection and/or break the abutment. Insufficientti ghtening of the abutment may result in the abutment falling into the patient’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 conception
See the Step C1
Step B3: inLink® prosthesis construction (dentallaboratory)
See the Step C2
Step B4: Place the inLink® locks into the inLink®prosthesis
See the Step C3
Step B5 (optional): 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 conception

Scan the platforms with the scan adapters and a laboratory scanner approved by Anthogyr.
For more information, please refer to the manuals listed in the “Further information” section.
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 construction (dental laboratory)
To perform the prosthesis work, use the laboratory locks and keep definitive locks for clinical use.
Build the definitive prosthesis:

Reception of the Simeda machined frame.
Before modifying or sandblasting the milled framework protect the inLink® connection with the protective 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 insertion, we recommend attaching two finalguiding locks to the framework. The guiding locks should be used on implants that have a relatively 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 inserting the ring into the fixation lock, make sure that the square notches in the ring point toward the tip 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. Otherwise, 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 pressing 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 patient’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 (optional): Try the inLink® prosthesis
Before screwing the prosthesis, ensure that the Axiom® TL implants and/or the inLink® abutments are free of any fluid or other substance that may compromise the proper fit of the prosthetic 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 insertion of the prosthesis, gradually pre-tighten the locks in a criss-cross pattern, starting 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 perpendicular to the connections.
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 fluid or other substance that may compromise the proper fit of the prosthetic compo- nent on the Axiom® TL implants and/or the inLink® abutments.
Over-ti ghtening the locks can deteriorate the implant connection and/or break the locks.
Insufficient tightening of the locks may result in the prosthesis falling into the patient’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 insertion of the prosthesis, gradually pre-tighten the locks in a criss-cross pattern, starting 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 perpendicular to the connections.
Close up the screw channel with Teflon, then seal with composite.

Step C6: Caring for the inLink® prosthesis
We recommend changing the locks every time the prosthesis is demounted.
Final locks pre-mounted on holders are available to facilitate insertion.
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.
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. Prosthetic screw for customised prosthesis
Over-tightening the screw can deteriorate the abutment connection and/or break the screw. Insufficient ti ghtening of the screw may result in the screw and/or the prosthesis falling into the patient’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 prosthetic 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 dynamometric wrench or with the hexagonal mandrel and the TORQ CONTROL®.
Close the screw channel.

Healing phase

The healing period required for osseointegration varies considerably and depends on the individual patient and treatment.
It is the sole responsibility of the surgeon to decide when the implant can be loaded.

Further information

For more information on the use of Anthogyr products, please contact your local Anthogyr sales representative or contact Anthogyr customer service or visit ifu.anthogyr.com and www.anthogyr.com. For more specific information on the Axiom® plural definitive abutments, please refer to:

Axiom® Multi Level® Prosthetic user guide (AXIOMMLP_NOT)
Customised prosthesis design user guide (MANUELCAD_NOT)

Subject to the availability of the European Medical Device Database (EUDAMED), the summary of safety and clinical performance characteristics (SSCP) is available at https://ec.europa.eu/tools/eudamed. Until Eudamed is fully functional, SSCP can be re- quested to Anthogyr at the following address: clinical@anthogyr.com.

Product Type	Basic UDI-DI
CoCr coping	36633940019QX
PACIFIC Kit	36633940011QF
Multi-Unit copings	PACIFIC ring
Prosthetic screws	DLC coated prosthetic screws
inLink® locks	DLC coated inLink® locks
inLink® locks	inLink® locks
Multi-Unit protective cap	Protective caps
Multi-Unit abutments inLink® abutments	Sterile Titanium abutment

36633940008QS

Storage

Store these products in a clean, dry area, at room temperature. Improper storage may compromise the essential characteristics of the materials and design, which may lead to device failure.

Waste treatment

Waste resulting from the intervention (packaging, part extracted, etc.) must be handled as medical waste under the responsibility of the user.

Patient information

Patients must accept regular medical follow-ups and should consult their doctor in the event of any unex-pected change in the performance of the prosthetic reconstitution. Patients must be informed of the need to ensure regular oral hygiene. Patient must be advised to remain cautious for the first few weeks after surgery. Traceability information is available to patients via the detachable labels on the device.

Notes

The practitioner must have the necessary knowledge to practice dental implantology and must be familiar with the handling instructions for Anthogyr products as described in this document in order to use Anthogyr products safely and in accordance with their instructions for use. Anthogyr products must be used in accordance with the manufacturer’s instructions for use. The dental surgeon is solely responsible for the proper use of Anthogyr products in accordance with their instruc- tions for use and to determine whether the product is suitable for the individual patient’s situation. Anthogyr products are part of a complete range and must be used in combination with the corresponding original components and instruments distributed by Anthogyr, its parent company and any affiliates or subsidiaries of the parent company (“Straumann”). The use of third-party products not distributed by Anthogyr voids any warranty or other obligation, express or implied, of Anthogyr. Any product-related issues must be reported to the local Anthogyr organisati on together with the prod- uct in question. In the event of a serious incident, the user must file a report with the local Anthogyr organisation and the appropriate competent authority in accordance with local regulati ons. Anthogyr also offers an online complaint service in the countries concerned.

Validity

The publication of this document supersedes and replaces all previous versions.
Anthogyr all rights reserved.
Anthogyr® and/or other trademarks and logos of Anthogyr® mentioned herein are trademarks or registered trademarks of Anthogyr.

Availability

Some components of the Anthogyr implant system are unavailable in certain countries.

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 product symbols.

Symbol	Symbol Description	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 instructions for use or consult electronic instructions for use	NF

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

Documents / Resources

| Anthogyr Axiom Plural Definitive Abutments [pdf] Instructions
Axiom Plural Definitive Abutments, Axiom, Plural Definitive Abutments, Definitive Abutments
---|---