Anthogyr dental implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.

Device Description

The AXIOM® PX implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The file concerns the implants and abutment screws. The prosthetic components and surgical instrumentation are the same as for the AXIOM® REG (see 510(k) K101913 and K131066) and are compatible with Axiom® PX implants. Implants: Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw. Material: Ti6AI4V-ELI Surface treatment: BCP® Dimensions, Ø3.4, length 8, 10, 12, 14, 16, 18 mm Ø 4.0, length 8, 10, 12, 14, 16, 18 mm Ø4.6, length 6.5, 8, 10, 12, 14 mm Ø5.2, length 6.5, 8, 10, 12 mm Screws: Screwing the abutment into the implant and the secondary parts into the abutment. Material: Ti6AI4V-ELI Surface treatment: DLC Dimensions: M1.4, length 5, 7.9 mm

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving a new device meets predefined acceptance criteria in the way a clinical trial for a novel AI device might. The "acceptance criteria" here are largely implied by the need to show equivalence to existing, legally marketed devices and adherence to relevant standards.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a dental implant system (AXIOM® PX), the "acceptance criteria" are primarily established by the performance characteristics of its predicate devices and compliance with relevant industry standards and FDA guidance. The study presented is a non-clinical performance testing suite designed to demonstrate substantial equivalence to these predicates.

Acceptance Criteria (Implied from Predicate Equivalence & Standards)	Reported Device Performance (AXIOM® PX)
Biomechanical Performance:	Biomechanical Testing:
- Conformance to ISO 14801 (2007) and FDA Special Controls Guidance Document for Root-form Endosseous Dental Implants.	- Static and fatigue testing conducted in air in accordance with ISO 14801 (2007) and Special Controls Guidance Document.
- Fatigue limit equivalent to predicate Axiom REG implants (K131066).	- The fatigue limit of Axiom PX has been compared to the predicate Axiom REG implants (K131066) fatigue limit. (Implies performance is equivalent).
- Equivalent surface area analysis, insertion torque, and pullout strength.	- Surface area analysis, insertion torque testing, and pullout strength testing included in the submission to demonstrate substantial equivalence.
Sterilization:	Sterilization Validation:
- Sterility of implants maintained through shelf-life, in accordance with ISO 11137 series standards.	- Gamma irradiation sterilization conducted on a representative worst-case implant, in accordance with ISO 11137 series standards. (Note: Sterilization was performed on the predicate device K131066. Both implants and DLC screws are sold sterile).
- Validated cleaning and sterilization parameters for end-user sterilized products (specifically DLC screws sold non-sterile) according to ISO 17665-1 and ISO 17665-2.	- Validation of recommended cleaning and sterilization parameters for end-user sterilized products (DLC screws) conducted according to ISO 17665-1 and ISO 17665-2.
Shelf-Life & Packaging Integrity:	Shelf-Life Validation:
- Product remains sterile throughout its shelf life, demonstrated by accelerated and real-time aging according to ASTM F1980.	- Shelf-life validated in accordance with ASTM F1980 under accelerated and real-time aging, supporting sterility throughout shelf life.
- Packaging integrity demonstrated by dye penetration (ASTM F1929-15), peeling, and seal strength (ASTM F88-15) tests.	- Dye penetration test (ASTM F1929-15), peeling testing, seal strength testing (ASTM F88-15) as well as sterility test were performed.
Biocompatibility:	Biocompatibility Testing:
- Conformance to ISO 10993 series standards.	- Biocompatibility assessment performed according to ISO 10993 series standards for implants and abutment screws.
- Implants: Assessment of extractable chemicals (ISO 10993-18:2005) and cytotoxicity (ISO 10993-5:2009).	- Implants: Chemical characterization (ISO 10993-18:2005) and cytotoxicity test (ISO 10993-5:2009) by exposing mouse fibroblast cells after extraction.
- Abutment screws: Assessment of extractable chemicals, cytotoxicity, intracutaneous irritation, and sensitization (ISO 10993-18:2005, ISO 10993-5:2009, ISO 10993-10:2010).	- Abutment screws: Chemical characterization (ISO 10993-18:2005), cytotoxicity test (ISO 10993-5:2009), intracutaneous study (ISO 10993-10:2010 - intradermal injection in rabbit), and sensitization study (ISO 10993-10:2010 - contact sensitization in albino guinea pig after polar and non-polar extraction).
Surface Analysis:	Surface Analysis:
- Microscopic analysis (SEM) of implant surface as required by FDA guidance.	- SEM for the implants as required by FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments).

Study Details

Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not specify the exact numerical sample sizes for each test (e.g., number of implants tested for fatigue, number of animals for biocompatibility). It generally refers to "representative worst case" scenarios for mechanical testing and indicates tests were performed.
- Data Provenance: The studies are non-clinical (laboratory/bench testing, and in-vitro/animal biocompatibility). Provenance is likely the testing labs approved by Anthogyr SAS, based in Sallanches, France. It is retrospective, meaning the tests were conducted prior to this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This is not applicable as the studies described are non-clinical performance and biocompatibility tests for a physical medical device (dental implant). The "ground truth" is established by adhering to widely accepted international standards (ISO, ASTM) and FDA guidance, with results interpreted by qualified laboratory personnel, rather than clinical experts establishing a diagnostic ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for non-clinical bench and biocompatibility testing. The methods are standardized and results are objectively measured per the specified test protocols (e.g., force to failure, chemical composition analysis, cell viability).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/Software as a Medical Device (SaMD) submission. It's a traditional physical medical device (dental implant) 510(k).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/SaMD submission.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the non-clinical tests is adherence to established, validated test methodologies and performance criteria outlined in international standards (ISO, ASTM) and FDA guidance documents. For example, for biocompatibility, the ground truth is whether the device elicits a toxic or inflammatory response as defined by the ISO 10993 series. For mechanical testing, it's whether the device meets or exceeds the strength and fatigue limits specified by ISO 14801 or exhibits equivalence to the predicate device.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this traditional medical device submission, as it does not involve machine learning or AI.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2017

ANTHOGYR SAS Therese Candau Regulatory Affairs Engineer 2237 Avenue Andre Lasquin Sallanches, 74700 FRANCE

Re: K161177

Trade/Device Name: Axiom® PX Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 12, 2017 Received: June 13, 2017

Dear Therese Candau:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -A

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161177

Device Name Axiom® PX

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

SECTION 5 510(K) SUMMARY

Section 5 – page 1 / 7 510(k) summary

{4}------------------------------------------------

510(k) SUMMARY

SUBMITTER'S CONTACT INFORMATION 5.1

ANTHOGYR SAS

2237, avenue André Lasquin SALLANCHES, FRANCE 74700 Registration Number: 8020776 Phone number: (33) (0)4 50 58 02 37 Fax number: (33) (0)4 50 93 78 60 Contact person: Thérèse CANDAU (m.candau@anthogyr.com) Preparation date: 06/14/2017

5.2 DEVICE

Trade name: AXIOM® PX Classification name: Endosseous Dental Implant Class II Product Code: DZE / NHA CFR Section: 21CFR 872.3640 Device panel: DENTAL 510(k) Number: K161177

5.3 PREDICATE DEVICE

Primary Predicate Device

K131066, AXIOM® REG manufactured by Anthogyr for implants

Reference Predicate Device

K101913, Anthogyr Dental Implant System: Axiom manufactured by Anthogyr

K992538, Amorphous diamond coated screw manufactured by NobelBiocare for attachment screws

{5}------------------------------------------------

The AXIOM® PX implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations.

The file concerns the implants and abutment screws. The prosthetic components and surgical instrumentation are the same as for the AXIOM® REG (see 510(k) K101913 and K131066) and are compatible with Axiom® PX implants.

Implants:

Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw.

Material: Ti6AI4V-ELI

Surface treatment: BCP®

Dimensions, Ø3.4, length 8, 10, 12, 14, 16, 18 mm Ø 4.0, length 8, 10, 12, 14, 16, 18 mm Ø4.6, length 6.5, 8, 10, 12, 14 mm

Ø5.2, length 6.5, 8, 10, 12 mm

Screws:

Screwing the abutment into the implant and the secondary parts into the abutment. Material: Ti6AI4V-ELI

Surface treatment: DLC

Dimensions: M1.4, length 5, 7.9 mm

INDICATIONS FOR USE 5.5

Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.

{6}------------------------------------------------

PERFORMANCE TESTING 5.6

ANTHOGYR AXIOM® PX conforms to Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff Document issued on May 12, 2004.

Sterilization validation

Gamma irradiation sterilization was conducted on a representative worst case implant in order to support sterility of the implants, in accordance with ISO 11137 series standards. Sterilization was performed on the predicate device (K131066).

Both implants and DLC screws are sold sterile.

Validation of the recommended cleaning and sterilization parameters for end-user sterilized products was conducted according to ISO 17665-1 and ISO 17665-2 to validate DLC screws sterilization when sold non sterile.

Shelf-life validation

The shelf-life has been validated in accordance with ASTM F1980 under accelerated and real-time ageing and supports that the product remains sterile throughout the shelf life. Dye penetration test (ASTM F1929-15), peeling testing, seal strength testing (ASTM F88-15) as well as sterility test were performed.

Biomechanical testing

Static and fatigue testing has been conducted on a representative worst case scenario in air in accordance with ISO 14801 (2007) and Special Controls Guidance Document : Root-form Endosseous Dental Implant and Endosseous Dental Abutments - Guidance for Industry and FDA Staff Document issued on May 12, 2004. The fatigue limit has been compared to the predicate Axiom REG implants fatique limit (K131066). Surface area analysis, insertion torque testing, and pullout strength testing has been included in this submission to demonstrate substantial equivalence.

Biocompatibility testing

Biocompatibility assessment has been performed according to ISO 10993 series standards for implants and abutment screws.

Implants:

Chemical characterization (ISO 10993-18:2005 – to determine the type and levels of extractable chemicals present).

{7}------------------------------------------------

Cytotoxicity test (ISO 10993-5:2009 - the cytotoxicity test is used to determine the biological response of mammalian cells in vitro by exposing mouse fibroblast cells after extraction).

Abutment screws:

Chemical characterization (ISO 10993-18:2005)

Cytotoxicity test (ISO 10993-5: 2009)

Intracutaneous study (ISO 10993-10:2010 - Intradermal injection of test extracts in the rabbit to evaluate the potential of the material to produce irritation).

Sensitization study (ISO 10993-10:2010 - to assess the contact sensitization potential of the device in the albino guinea pig after a polar and non-polar extraction).

Surface analysis

SEM for the implants as required by FDA guidance class II special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

TECHNOLOGICAL CHARACTERISTICS 5.7

5.7.1 Implants

	CandidateAxiom PX	PredicateAxiom REG	Comparison
Picture	Image: Axiom PX	Image: Axiom REG	The thread of the PXimplant is different fromthe REG implant in orderto easier the post-extractional placementand low-density bone
Material	Titanium: Ti6Al4V-ELI	Titanium: Ti6Al4V-ELI	Same material for bothimplants
Indicationsfor use	Anthogyr dental implantsare intended for use asartificial root structuresfor replacement of missingteeth. They can be usedfor stabilization ofremovable prostheses orfixation of single toothrestorations or partialdentures.Anthogyr dental systemsare indicated for one-stage or two-stage	Anthogyr dental implantsare intended for use asartificial root structures forreplacement of missingteeth. They can be used forstabilization of removableprostheses or fixation ofsingle tooth restorations orpartial dentures.The Axiom dental system isindicated for one-stage ortwo-stage surgery.It is up to the practitioner	The indications for useare the same for bothimplants. The indicationsfor Axiom REG includeboth implants andprosthetic partsindications.The Axiom PX indicationsinclude only the implantsindications as theprosthetic parts are notpresented here.

{8}------------------------------------------------

	surgery.It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.	to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations.
Compatibleabutments	Axiom REG AestheticabutmentsAxiom REG StandardabutmentsAxiom REG conicalabutmentsAxiom REG Healing screws	Axiom REG AestheticabutmentsAxiom REG StandardabutmentsAxiom REG conicalabutmentsAxiom REG Healing screws	Same compatibleabutments
Dimensions	Ø3.4 mm;Length 8-18 mmØ4.0 mm;Length 8-18 mmØ4.6 mm;Length 6.5-14 mmØ5.2 mm;Length 6.5-12 mm	Ø3.4 mm;Length: 8-18 mmØ4.0 mm;Length: 6.5-18 mmØ4.6 mm;Length: 6.5-14 mmØ5.2 mm;Length: 6.5-14 mm	The PX implantsdimensions available areincluded in the range ofREG implants
Surgicalapproach	One stage surgeryTwo stages surgeryImmediate loading	One stage surgeryTwo stages surgeryImmediate loading	The surgical approach isthe same
Surfacetreatment	sand blasting BCP +passivation	sand blasting BCP +passivation	Same treatment surfacefor both implants
Sterilizationmethod	Gamma radiation	Gamma radiation	Same sterilizationprocess for bothimplants

5.7.2 Abutment screws

	CandidateAxiom PX screw	PredicateNobelBiocare	Comparison
Material	Titanium: Ti6Al4V-ELI	Titanium: Ti6Al4V-ELI	Both made from samematerial
Indicationsfor use	Anthogyr dental implantsare intended for use asartificial root structures forreplacement of missingteeth. They can be used forstabilization of removableprostheses or fixation ofsingle tooth restorations orpartial dentures.Anthogyr dental systemsare indicated for one-stage	The Amorphous DiamondCoated Screw is used toretain prostheticcomponents to dentalimplants or to otherprosthetic components. Theamorphous diamondcoating will add a greaterpre-load to the screw,which in turn help preventthe screw and prosthetic	The indication for thepredicate is specific tothe Diamond CoatedScrew, while theindication for thesubject devicedescribes the entireimplant system,including the Axiom PXscrew.

{9}------------------------------------------------

	or two-stage surgery.It is up to the practitionerto decide whetherimmediate or delayedloading is most appropriate,based on clinical factors likegood primary stability andappropriate occlusalloading.	components fromloosening.
Compatibleabutments	Axiom REG AestheticabutmentsAxiom REG StandardabutmentsAxiom REG conicalabutments	Pre-fabricated titaniumabutments compatible withNobelActive implants	Each system has itsown compatible range
Connectiontype	Internal conical connection	Internal conical connection	Both internal conicalconnection
Surfacetreatment	Diamond Like Carbon	Diamond Like Carbon	Both DLC surfacetreatment
Sterilizationmethod	Delivered not sterile orsterile with abutment	Delivered not sterile	Anthogyr screw can bedelivered sterile. Thesterilization methodhas been validated

5.8 CONCLUSION

ANTHOGYR AXIOM® PX is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function. Non clinical performance testing according to special control demonstrate that ANTHOGYR AXIOM® PX is substantially equivalent to its predicate device.

The mechanical testing shows that the performance of the Axiom PX implants is substantially equivalent to the predicate device.

Based on technological characteristics included in this submission, the Axiom PX implants have been shown to be substantially equivalent to the Axiom REG implants.

{0}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2017

ANTHOGYR SAS Therese Candau Regulatory Affairs Engineer 2237 Avenue Andre Lasquin Sallanches, 74700 FRANCE

Re: K161177

Dear Therese Candau:

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -A

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161177

Device Name Axiom® PX

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

SECTION 5 510(K) SUMMARY

Section 5 – page 1 / 7 510(k) summary

{4}------------------------------------------------

510(k) SUMMARY

SUBMITTER'S CONTACT INFORMATION 5.1

ANTHOGYR SAS

5.2 DEVICE

Trade name: AXIOM® PX Classification name: Endosseous Dental Implant Class II Product Code: DZE / NHA CFR Section: 21CFR 872.3640 Device panel: DENTAL 510(k) Number: K161177

5.3 PREDICATE DEVICE

Primary Predicate Device

K131066, AXIOM® REG manufactured by Anthogyr for implants

Reference Predicate Device

K101913, Anthogyr Dental Implant System: Axiom manufactured by Anthogyr

K992538, Amorphous diamond coated screw manufactured by NobelBiocare for attachment screws

{5}------------------------------------------------

The AXIOM® PX implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations.

Implants:

Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw.

Material: Ti6AI4V-ELI

Surface treatment: BCP®

Dimensions, Ø3.4, length 8, 10, 12, 14, 16, 18 mm Ø 4.0, length 8, 10, 12, 14, 16, 18 mm Ø4.6, length 6.5, 8, 10, 12, 14 mm

Ø5.2, length 6.5, 8, 10, 12 mm

Screws:

Screwing the abutment into the implant and the secondary parts into the abutment. Material: Ti6AI4V-ELI

Surface treatment: DLC

Dimensions: M1.4, length 5, 7.9 mm

INDICATIONS FOR USE 5.5

{6}------------------------------------------------

PERFORMANCE TESTING 5.6

Sterilization validation

Both implants and DLC screws are sold sterile.

Shelf-life validation

Biomechanical testing

Biocompatibility testing

Biocompatibility assessment has been performed according to ISO 10993 series standards for implants and abutment screws.

Implants:

Chemical characterization (ISO 10993-18:2005 – to determine the type and levels of extractable chemicals present).

{7}------------------------------------------------

Cytotoxicity test (ISO 10993-5:2009 - the cytotoxicity test is used to determine the biological response of mammalian cells in vitro by exposing mouse fibroblast cells after extraction).

Abutment screws:

Chemical characterization (ISO 10993-18:2005)

Cytotoxicity test (ISO 10993-5: 2009)

Intracutaneous study (ISO 10993-10:2010 - Intradermal injection of test extracts in the rabbit to evaluate the potential of the material to produce irritation).

Sensitization study (ISO 10993-10:2010 - to assess the contact sensitization potential of the device in the albino guinea pig after a polar and non-polar extraction).

Surface analysis

SEM for the implants as required by FDA guidance class II special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.

TECHNOLOGICAL CHARACTERISTICS 5.7

5.7.1 Implants

	CandidateAxiom PX	PredicateAxiom REG	Comparison
Picture	Image: Axiom PX	Image: Axiom REG	The thread of the PXimplant is different fromthe REG implant in orderto easier the post-extractional placementand low-density bone
Material	Titanium: Ti6Al4V-ELI	Titanium: Ti6Al4V-ELI	Same material for bothimplants
Indicationsfor use	Anthogyr dental implantsare intended for use asartificial root structuresfor replacement of missingteeth. They can be usedfor stabilization ofremovable prostheses orfixation of single toothrestorations or partialdentures.Anthogyr dental systemsare indicated for one-stage or two-stage	Anthogyr dental implantsare intended for use asartificial root structures forreplacement of missingteeth. They can be used forstabilization of removableprostheses or fixation ofsingle tooth restorations orpartial dentures.The Axiom dental system isindicated for one-stage ortwo-stage surgery.It is up to the practitioner	The indications for useare the same for bothimplants. The indicationsfor Axiom REG includeboth implants andprosthetic partsindications.The Axiom PX indicationsinclude only the implantsindications as theprosthetic parts are notpresented here.

{8}------------------------------------------------

	surgery.It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.	to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations.
Compatibleabutments	Axiom REG AestheticabutmentsAxiom REG StandardabutmentsAxiom REG conicalabutmentsAxiom REG Healing screws	Axiom REG AestheticabutmentsAxiom REG StandardabutmentsAxiom REG conicalabutmentsAxiom REG Healing screws	Same compatibleabutments
Dimensions	Ø3.4 mm;Length 8-18 mmØ4.0 mm;Length 8-18 mmØ4.6 mm;Length 6.5-14 mmØ5.2 mm;Length 6.5-12 mm	Ø3.4 mm;Length: 8-18 mmØ4.0 mm;Length: 6.5-18 mmØ4.6 mm;Length: 6.5-14 mmØ5.2 mm;Length: 6.5-14 mm	The PX implantsdimensions available areincluded in the range ofREG implants
Surgicalapproach	One stage surgeryTwo stages surgeryImmediate loading	One stage surgeryTwo stages surgeryImmediate loading	The surgical approach isthe same
Surfacetreatment	sand blasting BCP +passivation	sand blasting BCP +passivation	Same treatment surfacefor both implants
Sterilizationmethod	Gamma radiation	Gamma radiation	Same sterilizationprocess for bothimplants

5.7.2 Abutment screws

	CandidateAxiom PX screw	PredicateNobelBiocare	Comparison
Material	Titanium: Ti6Al4V-ELI	Titanium: Ti6Al4V-ELI	Both made from samematerial
Indicationsfor use	Anthogyr dental implantsare intended for use asartificial root structures forreplacement of missingteeth. They can be used forstabilization of removableprostheses or fixation ofsingle tooth restorations orpartial dentures.Anthogyr dental systemsare indicated for one-stage	The Amorphous DiamondCoated Screw is used toretain prostheticcomponents to dentalimplants or to otherprosthetic components. Theamorphous diamondcoating will add a greaterpre-load to the screw,which in turn help preventthe screw and prosthetic	The indication for thepredicate is specific tothe Diamond CoatedScrew, while theindication for thesubject devicedescribes the entireimplant system,including the Axiom PXscrew.

{9}------------------------------------------------

	or two-stage surgery.It is up to the practitionerto decide whetherimmediate or delayedloading is most appropriate,based on clinical factors likegood primary stability andappropriate occlusalloading.	components fromloosening.
Compatibleabutments	Axiom REG AestheticabutmentsAxiom REG StandardabutmentsAxiom REG conicalabutments	Pre-fabricated titaniumabutments compatible withNobelActive implants	Each system has itsown compatible range
Connectiontype	Internal conical connection	Internal conical connection	Both internal conicalconnection
Surfacetreatment	Diamond Like Carbon	Diamond Like Carbon	Both DLC surfacetreatment
Sterilizationmethod	Delivered not sterile orsterile with abutment	Delivered not sterile	Anthogyr screw can bedelivered sterile. Thesterilization methodhas been validated

5.8 CONCLUSION

The mechanical testing shows that the performance of the Axiom PX implants is substantially equivalent to the predicate device.

Based on technological characteristics included in this submission, the Axiom PX implants have been shown to be substantially equivalent to the Axiom REG implants.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.