ANTHOGYR Dental Implant System implant AXIOM is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Device Description

AXIOM dental implant system is designed to enhance the functional and aesthetic integration of implant supported restorations. AXIOM implants are made of grade V titanium and present a single connection (2.7 mm) common to all implant forms in the range. AXIOM implants are available in 4 diameters (3.4, 4.0, 4.6 and 5.2 mm) and various heights from 8 to 14 mm. AXIOM dental implant system includes all required prosthetic components and surgical instrumentation.

AI/ML Overview

The provided text details the 510(k) summary for the ANTHOGYR DENTAL IMPLANT SYSTEMS: AXIOM, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than describing a performance study with acceptance criteria for an AI/ML-driven device.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC study, standalone performance, ground truth establishment, and training set details for an AI/ML device) is not present in the provided 510(k) summary.

This document primarily covers:

Device Description: What the AXIOM implant system is, its materials, sizes, and components.
Intended Use: The medical conditions and applications for which the device is designed.
Performance Data (Non-clinical): Mentions fatigue testing, implant-to-abutment compatibility, corrosion testing, and modified surfaces information.
Clinical Data: Explicitly states "None included."
Substantial Equivalence: Compares the AXIOM system to its predicate device (PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM - K051614) based on intended use, material, design, mechanical properties, and function.
Regulatory Information: Product codes, classifications, and panel.
FDA Communication: The letter from the FDA affirming the substantial equivalence determination and outlining regulatory responsibilities.

Since the device is a dental implant system and not an AI/ML-driven diagnostic or therapeutic tool, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, reader studies, etc.) are not applicable to this document. The "performance data" referred to here are engineering and material performance tests, not clinical performance or AI algorithm performance.

Summary

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

12 3

Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text reads 'K10/913' and is underlined with a curved line. The handwriting is cursive and the numbers are separated by a forward slash.

510(k) SUMMARY

MAR 1 1 2011

As required by section 807.92(c)

Submitter	ANTHOGYR SAS2237, avenue Andre LasquinSALLANCHES, FRANCE 74700Registration Number: 8020776
Contacts	Eric GENEVE e.geneve@anthogyr.comPhone (33) (0)4 50 58 02 37 Fax (33) (0)4 50 93 78 60Regulatory: Dr Isabelle DRUBAIX (PhD) IDEE CONSULTINGidrubaix@nordnet.fr
Preparation date	June 16, 2010
Trade Name	ANTHOGYR DENTAL IMPLANT SYSTEMS : AXIOM
Classification Name	ENDOSSEOUS DENTAL IMPLANT
Class	II
Product Code	DZE
CFR section	21CFR 872.3640
Device panel	DENTAL
Legally marketed predicate devices	PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM(K051614)

Description

AXIOM dental implant system includes all required prosthetic components and surgical instrumentation.

Intended Use

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

K101913

Performance data

ANTHOGYR Endosseous dental implant system AXIOM conforms to Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments issued on May 12, 2004. Non clinical performance data presented within the submission included: Fatigue testing, Implant to abutment compatibility, corrosion testing and modified surfaces information.

Clinical data

None included

Substantial equivalence

ANTHOGYR Endosseous dental implant system AXIOM is substantially equivalent to its predicate device in terms of intended use, material, design, mechanical properties and function.

Image: AXIOM PRIMACONNEX (KO51614)
21CFR / Product's code / Panel	21CFR 872.3640 / DZE / DENTAL PANEL
Indications for use statement	Both Dental Implant Systems are intended for use in partiallyor fully edentulous mandibles and maxillae, in support ofsingle or multiple-unit restorations including; cementretained, screw retained, or overdenture restorations, andterminal or intermediate abutment support for fixedbridgework.
Device	Root form endosseous dental implants and abutments
Range of products	Both Dental Implant Systems include implants, abutments,all required prosthetic components and surgicalinstrumentation
Design and models	Internal lobe connection
	Designed to allow clinical flexibility in a single implant system- Time-saving technologies - Intuitive user-friendly design
	Implants made of Titanium
	Unique prosthetic platformImplant Φ: 3.4 -5.2 mmImplant Lengths: 8-14 mm 3 prosthetic platformsImplant Φ: 3.5 -5.0 mmImplant Lengths: 10-15 mm
Surface treatment	Sand blasting roughened surface
	using calcium phosphate resorbable blast media
	Bi Calcium Phosphate (BCP) Resorbable Blast Media (RBM)
Sterilization	Single-use - Provided sterile - Gamma radiation
Labeling	Both Dental Implant Systems share same intended use,contra-indications, warnings precautions and potentialadverse events
Performance	Both Dental Implant Systems conform to Class II SpecialControls Guidance Document:: Root-form Endosseous DentalImplants and Endosseous Dental Abutments - Guidance forIndustry and FDA Staff Document issued on May 12, 2004

Performance data included within this submission demonstrates safety, effectiveness and substantial equivalence. Revised January 20, 2011

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

K101913

. .

383

The table under Tab 4, on page 44/45 indicates that your OSSFIT has abutments. This table is incorrect because this implant is a one piece implant. Please submit a revised table.

Not applicable – OSSFIT has been deleted from K101913

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged around a circular emblem. The emblem includes a stylized representation of an eagle or bird-like figure, composed of three curved lines or strokes.

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

Mr. Eric Geneve CEO ANTHOGYR SAS 2237 avenue Andre Lasquin SALLANCHES, FRANCE 74700

MAR 1 1 201

Re: K101913

Trade/Device Name: Anthogyr Dental Implant System: Axiom Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 1, 2011 Received: March 7, 2011

Dear Mr. Geneve:

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.

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

Page 2- Mr. Geneve

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 (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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Anthony D. Awtrey

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K10/913

INDICATIONS FOR USE

510(k) Number (if known): Device Name: ANTHOGYR DENTAL IMPLANT SYSTEM: AXIOM

Indications for Use:

ANTHOGYR Dental Implant System AXIOM is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture intermediate abutment support for fixed restorations, and terminal or bridgework.

Prescription Use	✓
(Part 21 CFR 801 Subpart D)
	AND/OR
Over-The-Counter Use
(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)

(Division Sign-Off) Bivision of Anesthesiology, General Hospital Infection Control, Dental Devices Page 10 / 142

510(k) Number: K101913

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.