AXIOM REG

K131066 · Anthogyr Sas · DZE · Feb 21, 2014 · Dental

Device Facts

• Record ID: K131066
• Device Name: AXIOM REG
• Applicant: Anthogyr Sas
• Product Code: DZE · Dental
• Decision Date: Feb 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Anthogyr AXIOM® REG 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. The Axiom dental system is 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. Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations.

Device Story

AXIOM® REG system comprises endosseous dental implants and prosthetic components (abutments, healing screws, caps). Implants serve as artificial roots for missing teeth; placed in upper or lower jaw. Components support permanent or temporary restorations, including single-unit, multiple-unit, or full-arch screw-retained/cemented prostheses. System features unique prosthetic connection allowing assembly of any abutment on any implant diameter. Used by dental practitioners in clinical settings. Benefits include functional and aesthetic restoration of dentition. Mechanical performance validated via fatigue testing.

Clinical Evidence

No clinical data presented. Substantial equivalence supported by bench testing, specifically fatigue testing conducted in accordance with NF EN ISO 14801 (2007) and compliance with the FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments'.

Technological Characteristics

Materials: Ti6Al4V alloy, PMMA. Surface treatment: BCP®. Components: Implants (Ø3.4-4.0mm), conical/aesthetic/standard angulated/temporary abutments, healing screws, caps. Mechanical testing: Fatigue testing per NF EN ISO 14801. Sterilization: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring replacement of missing teeth via artificial root structures. Supports stabilization of removable prostheses or fixation of single/partial tooth restorations. Suitable for one-stage or two-stage surgical procedures. Practitioner determines immediate or delayed loading based on primary stability and occlusal factors.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AXIOM dental Implant system (K101913)
• Nobel Speedy Replace (K050406)
• Dentsply Friadent implant system - XIVE S Plus (K073075)
• Dentsply Ankylos C/X (K083805)

Submission Summary (Full Text)

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FEB 2 1 2014

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# 510(k) SUMMARY

| | ANTHOGYR SAS |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | 2237, avenue Andre Lasquin<br>SALLANCHES, FRANCE 74700<br>Registration Number: 8020776 |
| Contacts | Ms Thérèse CANDAU m,[e-mail]<br>Phone (33) (0)4 50 58 02 37 Fax (33) (0)4 50 93 78 60<br>Regulatory: Dr Isabelle DRUBAIX (PhD) IDEE CONSULTING<br>[e-mail] |
| Trade Name | AXIOM® REG |
| Classification | ENDOSSEOUS DENTAL IMPLANT |
| Name | ENDOSSEOUS DENTAL ABUTMENT |
| Class | II |
| Product Code | DZE<br>NHA |
| CFR section | 21CFR 872.3640 |
| Device panel | DENTAL |
| Legally marketed<br>predicate devices | AXIOM dental Implant system K101913<br>Nobel Speedy Replace K050406<br>Dentsply Friadent implant system - XIVE S Plus K073075<br>Dentsply Ankylos C/X K083805 |
| Description | The AXIOM® REG Implant system has been designed in order to enhance<br>the functional and aesthetic integration of implant supported restorations..<br>The file concerns the expansion of prosthetic components and surgical<br>instrumentation and also the implants of the AXIOM® REG.<br><br>Any abutment can be assembled on any AXIOM® REG implant thanks to its<br>unique prosthetic connection, regardless of the implant diameter chosen.<br><br>- Implants<br>Replacement of a missing root for placement of a dental restoration. The<br>implant is screwed in the upper or lower jaw.<br>Material: Ti6Al4V<br>Surface treatment: BCP®<br>Dimensions: Ø3.4 mm, length: 16-18 mm<br>Ø 4.0 mm, length: 16-18 mm<br><br>- Conical abutments<br>Provide support for a permanent restoration, for multiple screw-retained<br>prosthesis and screw-retained bar and brace<br>Material: Ti6Al4V<br>Dimensions: gingival height: 4.5 mm<br>angle: 18-30°<br>Rotational and non rotational abutments.<br><br>- Aesthetic titanium abutments<br>Provide support for a permanent restoration, single and multiple-unit<br>cemented restoration.<br>Material: Ti6Al4V<br>Dimensions: Ø3.4 mm; gingival height: 2.5-4.5 mm; angle: 7-15° |
| Ø4.0 mm; gingival height: 0.75-4.5 mm; angle: 0-23° | |
| Ø5.0 mm; gingival height: 0.75-4.5 mm; angle: 0-23° | |
| Ø6.0 mm; gingival height: 1.5-4.5 mm; angle: 0-15° | |
| Standard angulated titanium abutments | |
| Provide support for a permanent restoration | |
| Material: Ti6Al4V | |
| Dimensions: Ø4.0 mm; gingival height: 1.5-3.5 mm; angle 15-23° | |
| Ø5.0 mm; gingival height: 1.5-3.5 m; angle 15-23° | |
| Temporary abutments | |
| Provide support for a temporary restoration | |
| Material: Ti6Al4V | |
| Dimensions: Ø3.4 mm; height: 1.5-4.5 mm | |
| Ø4.0 mm; height: 0.75-4.5 mm | |
| Ø5.0 mm; height: 0.75-4.5 mm | |
| Ø6.0 mm; height: 1.5-4.5 mm | |
| Healing screws and healing screws flat<br>Sealing of implant conical connection during bone healing. Prepare gingiva to the permanent restoration shape. | |
| Material: Ti6Al4V | |
| Dimensions: Ø3.4 mm; height: 4.5 mm | |
| Ø4.0 mm; height: 0.75-4.5 mm | |
| Ø5.0 mm; height: 0.75-4.5 mm | |
| Ø6.0 mm; height: 4.5 mm | |
| Dimensions (flat version): Ø3.4 mm; height: 1.5-4.5 mm | |
| Ø4.0 mm; height: 0.75-4.5 mm | |
| Ø5.0 mm; height: 0.75-4.5 mm | |
| Ø6.0 mm; height: 1.5-4.5 mm | |
| Pacific system | |
| Ensure passive fit between the conical abutment and the framework.<br>Reserved exclusively for multiple or full-arch screw-retained prostheses on straight conical abutments. | |
| Materials: Ti6Al4V, PMMA | |
| Temporary cap and protecting cap<br>Give the negative shape of the permanent abutment for the design and realization by casting (lost wax process) of a dental restoration | |
| Anthogyr AXIOM® REG 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.<br>The Axiom dental system is indicated for one-stage or two-stage surgery. | |
| Indications for use | 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.<br>Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations. |

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| | Performance data | AXIOM® Endosseous dental implant systems (AXIOM® REG) conforms to<br>Class II Special Controls Guidance Document: Root-form Endosseous Dental<br>Implants and Endosseous Dental Abutments - Guidance for Industry and<br>FDA Staff Document issued on May 12, 2004.<br>A fatigue testing according to the standard NF EN ISO 14801 (2007) has<br>been performed for added devices.<br>Results demonstrate comparable mechanical properties to the predicate<br>device. No clinical data has been presented. |
|------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Substantial<br>equivalence | ANTHOGYR Endosseous dental implant systems (AXIOM® REG) is<br>substantially equivalent to its predicate devices in terms of intended use,<br>material, design, mechanical properties and function. Non clinical<br>performance testing according to special control demonstrate that<br>ANTHOGYR Endosseous dental implant system (AXIOM® REG) is as safe,<br>effective, and performs as safely and effectively as its predicate devices. |
| Preparation date | February 19th 2014 | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

February 21, 2014

Ms. Therese Candau Regulatory Affairs Engineer Anthogyr SAS 2237 Avenue Andre Lasquin Sallanches, FRANCE 74700

Re: K131066

Trade/Device Name: Axiom REG Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: January 15, 2014 Received: January 22, 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 - Mr. Candau

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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for

Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befoly.

510(k) Number (if known) KIJ 1066

Device Name AXION REG

#### Indications for Use (Describe)

Anthogyr AXIOM® REG 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. The Axiom dental system is 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.

Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations.

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

2 Prescription Use {Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Mary S. Runner -S<br>Susan Runner DDS, MA 2014.02.21<br>09:42:24′-05'00' |
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