ANTHOGYR implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for fixation of single tooth restorations.
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.
Axiom® 2.8 implants are indicated for single replacement of mandibular incisors and lateral maxillary incisors in cases presenting a restricted mesiodistal space.
The prosthetic components of the Axiom 2.8 product line are intended to ensure support for single crowns only.

Device Description

The AXIOM® 2.8 implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The implant-abutment combination can support occlusal charge without risk of damaging the restoration and will not generate hazardous peek of stress at the prosthetic interface level.
The file concerns the implants and abutments.
Implants:
Replacement of a missing root for placement of a dental restoration.
Material: Ti6Al4V
Surface treatment: BCP®
Dimensions: Ø2.8, length: 10-14 mm
Abutments:
Provide support for a single permanent restoration.
Material: Ti6Al4V
Dimensions: Ø2.8
Angle: 0-23°
Gingival height: 1-5.5 mm
Temporary abutments:
Provide support for a temporary restoration.
Material: PEEK
Dimensions:Ø2.8
Gingival height: 1-5.5 mm

AI/ML Overview

The provided text is a 510(k) Summary for the ANTHOGYR AXIOM® 2.8 endosseous dental implant system. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Defined by special controls and ISO standard)	Reported Device Performance (from fatigue testing)	Device Meets Criteria?
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.	Not explicitly stated how conformity was demonstrated beyond fatigue testing.	Yes (implied by "conforms to" statement)
Mechanical properties as per ISO 14801 (2007) for fatigue testing.	"Results demonstrate comparable mechanical properties to the predicate device."	Yes (implied by comparability to predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document mentions "a fatigue testing," but doesn't specify the number of samples tested.
Data Provenance: The study was conducted by ANTHOGYR SAS, located in Sallanches, France. It is a non-clinical in vitro test (fatigue testing), not involving human or animal subjects, so terms like "retrospective" or "prospective" are not applicable.

3. 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 section is not applicable. The "ground truth" here refers to the performance of the device against a defined standard (ISO 14801 for mechanical properties). This is an objective measurement based on a standardized test, not a subjective interpretation by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. As stated above, the performance assessment is based on objective, standardized mechanical testing, not a subjective interpretation requiring adjudication.

5. 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

This section is not applicable. This device is an endosseous dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. This device is a physical medical device (dental implant), not an algorithm or software. Its performance is assessed through physical, mechanical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by the ISO 14801 (2007) standard for fatigue testing and the mechanical properties of the legally marketed predicate device. The goal of the study was to demonstrate comparable mechanical properties to the predicate, ensuring the new device performs at least as safely and effectively.

8. The sample size for the training set

This section is not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

This section is not applicable. There is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The emblem is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

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

September 17, 2014

Anthogyr SAS Ms. Thérése Candau Regulatory Affairs Engineer 2237 Avenue Andre Lasquin Sallanches, France 74700

Re: K141450

Trade/Device Name: Axiom® 2.8 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 26, 2014 Received: September 3, 2014

Dear Ms. 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.

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Page 2 - Ms. Candau

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATIONS FOR USE

510(k) Number (if known): ___

Device Name: AXIOM® 2.8

Indications for Use:

ANTHOGYR implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for fixation of single tooth restorations.

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.

Axiom® 2.8 implants are indicated for single replacement of mandibular incisors and lateral maxillary incisors in cases presenting a restricted mesiodistal space.

The prosthetic components of the Axiom 2.8 product line are intended to ensure support for single crowns only.

Prescription Use >I Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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SECTION 5 510(K) SUMMARY

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510(k) SUMMARY

	ANTHOGYR SAS
Submitter	2237, avenue Andre Lasquin
	SALLANCHES, FRANCE 74700
	Registration Number: 8020776
Contacts	Ms. Thérèse CANDAU m.candau@anthogyr.com
	Phone: (33) (0)4 50 58 02 37 Fax (33) (0)4 50 93 78 60
	Regulatory: Dr. Isabelle DRUBAIX (PhD) IDEE CONSULTING
	idrubaix@nordnet.fr
Trade Name	AXIOM® 2.8
Classification Name	ENDOSSEOUS DENTAL IMPLANT
Class	II
Product Code	DZE / NHA
CFR section	21CFR 872.3640
Device panel	DENTAL
Legally marketedpredicate devices	Axiom® REG (K101913/K131066) manufactured by Anthogyr
	NobelActive 3.0 (K102436) manufactured by Nobel Biocare
	3.0 mm Integra CP Implant (K101849) manufactured by Bicon
	Sendax MDI and MDI PLUS (K031106) manufactured by
	Imtec
Description	The AXIOM® 2.8 implant system has been designed in orderto enhance the functional and aesthetic integration of implantsupported restorations. The implant-abutment combinationcan support occlusal charge without risk of damaging therestoration and will not generate hazardous peek of stress atthe prosthetic interface level.
	The file concerns the implants and abutments.
	Implants:
	Replacement of a missing root for placement of a dentalrestoration.
	Material: Ti6Al4V
	Surface treatment: BCP®
	Dimensions: Ø2.8, length: 10-14 mm

	Abutments:
	Provide support for a single permanent restoration.
	Material: Ti6Al4V
	Dimensions: Ø2.8
	Angle: 0-23°
	Gingival height: 1-5.5 mm
	Temporary abutments:Provide support for a temporary restoration.Material: PEEKDimensions:Ø2.8Gingival height: 1-5.5 mm
Indications for use	ANTHOGYR Axiom® implants are intended for use as artificialroot structures for replacement of missing teeth. They can beused for fixation of single tooth restorations.ANTHOGYR dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whetherimmediate or delayed loading is most appropriate, based onclinical factors like good primary stability and appropriateocclusal loading.Axiom® 2.8 implants are indicated for single replacement ofmandibular incisors and lateral maxillary incisors in casespresenting a restricted mesiodistal space.The prosthetic components of the Axiom 2.8 product line areintended to ensure support for single crowns only.
Performance data	ANTHOGYR AXIOM® 2.8 conforms to Class II Special ControlsGuidance Document: Root-form Endosseous Dental Implantsand Endosseous Dental Abutments - Guidance for Industryand FDA Staff Document issued on May 12, 2004.A fatigue testing according to the standard ISO 14801 (2007)has been performed.Results demonstrate comparable mechanical properties to thepredicate device. No clinical data has been presented.
Substantialequivalence	ANTHOGYR AXIOM® 2.8 is substantially equivalent to itspredicate devices in terms of intended use, material, design,mechanical properties and function. Non clinical performancetesting according to special control demonstrate thatANTHOGYR Endosseous dental implant system AXIOM® 2.8 isas safe, as effective, and performs as safely and effectively asits predicate devices.
Preparation date	August 8th, 2014

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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.