(311 days)
Not Found
No
The 510(k) summary describes a system of dental implants and prosthetic components made of standard materials (Ti6Al4V, PMMA). There is no mention of software, algorithms, image processing, or any terms related to AI/ML in the intended use, device description, or performance studies. The performance studies focus on mechanical properties, not algorithmic performance.
Yes
The device is intended to replace missing teeth, acting as artificial root structures and supporting dental restorations, which falls under the definition of a therapeutic device as it treats a condition (missing teeth).
No
The device description clearly states its purpose as "artificial root structures for replacement of missing teeth" and as a "dental system" for implant-supported restorations. It involves implants and various abutments for structural support, not for obtaining or interpreting physiological data for diagnosis.
No
The device description explicitly details various physical components made of Ti6Al4V and PMMA, such as implants, abutments, healing screws, and caps, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Anthogyr AXIOM® REG implants are used as "artificial root structures for replacement of missing teeth." This is a surgical and prosthetic application, not a diagnostic one.
- Device Description: The description details the physical components of the dental implant system (implants, abutments, screws, etc.) and their materials and dimensions. These are all physical devices implanted or used in the mouth.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are designed for diagnostic purposes.
The device is a dental implant system, which falls under the category of medical devices used for treatment and restoration, not in vitro diagnosis.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The AXIOM® REG Implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations.
The file concerns the expansion of prosthetic components and surgical instrumentation and also the implants of the AXIOM® REG.
Any abutment can be assembled on any AXIOM® REG implant thanks to its unique prosthetic connection, regardless of the implant diameter chosen.
-
Implants
Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw.
Material: Ti6Al4V
Surface treatment: BCP®
Dimensions: Ø3.4 mm, length: 16-18 mm
Ø 4.0 mm, length: 16-18 mm -
Conical abutments
Provide support for a permanent restoration, for multiple screw-retained prosthesis and screw-retained bar and brace
Material: Ti6Al4V
Dimensions: gingival height: 4.5 mm
angle: 18-30°
Rotational and non rotational abutments. -
Aesthetic titanium abutments
Provide support for a permanent restoration, single and multiple-unit cemented restoration.
Material: Ti6Al4V
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
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.
Reserved exclusively for multiple or full-arch screw-retained prostheses on straight conical abutments.
Materials: Ti6Al4V, PMMA
Temporary cap and protecting cap
Give the negative shape of the permanent abutment for the design and realization by casting (lost wax process) of a dental restoration
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper or lower jaw (for implant placement)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Practitioner (implied dental professional)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A fatigue testing according to the standard NF EN ISO 14801 (2007) has been performed for added devices. Results demonstrate comparable mechanical properties to the predicate device. No clinical data has been presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AXIOM dental Implant system K101913, Nobel Speedy Replace K050406, Dentsply Friadent implant system - XIVE S Plus K073075, Dentsply Ankylos C/X K083805
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
FEB 2 1 2014
.
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® REG |
| Classification | ENDOSSEOUS DENTAL IMPLANT |
| Name | ENDOSSEOUS DENTAL ABUTMENT |
| Class | II |
| Product Code | DZE |
| NHA | |
| CFR section | 21CFR 872.3640 |
| Device panel | DENTAL |
| Legally marketed | |
| predicate devices | AXIOM dental Implant system K101913 |
| Nobel Speedy Replace K050406 | |
| Dentsply Friadent implant system - XIVE S Plus K073075 | |
| Dentsply Ankylos C/X K083805 | |
| Description | The AXIOM® REG Implant system has been designed in order to enhance |
| the functional and aesthetic integration of implant supported restorations.. | |
| The file concerns the expansion of prosthetic components and surgical | |
| instrumentation and also the implants of the AXIOM® REG. |
Any abutment can be assembled on any AXIOM® REG implant thanks to its
unique prosthetic connection, regardless of the implant diameter chosen.
-
Implants
Replacement of a missing root for placement of a dental restoration. The
implant is screwed in the upper or lower jaw.
Material: Ti6Al4V
Surface treatment: BCP®
Dimensions: Ø3.4 mm, length: 16-18 mm
Ø 4.0 mm, length: 16-18 mm -
Conical abutments
Provide support for a permanent restoration, for multiple screw-retained
prosthesis and screw-retained bar and brace
Material: Ti6Al4V
Dimensions: gingival height: 4.5 mm
angle: 18-30°
Rotational and non rotational abutments. -
Aesthetic titanium abutments
Provide support for a permanent restoration, single and multiple-unit
cemented restoration.
Material: Ti6Al4V
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
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.
Reserved exclusively for multiple or full-arch screw-retained prostheses on straight conical abutments. | |
| Materials: Ti6Al4V, PMMA | |
| Temporary cap and protecting cap
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.
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.
Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations. |
Section 5 - page 2 / 4
:
1
Section 5 - page 3 / 4
:
and the same of the same
.
2
| | Performance data | AXIOM® Endosseous dental implant systems (AXIOM® REG) 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.
A fatigue testing according to the standard NF EN ISO 14801 (2007) has
been performed for added devices.
Results demonstrate comparable mechanical properties to the predicate
device. No clinical data has been presented. |
|------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Substantial
equivalence | ANTHOGYR Endosseous dental implant systems (AXIOM® REG) 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 Endosseous dental implant system (AXIOM® REG) is as safe,
effective, and performs as safely and effectively as its predicate devices. |
| Preparation date | February 19th 2014 | |
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, with three curved lines representing its wings.
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.
4
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 (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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/4/Picture/7 description: The image shows the name Kwame Ulmer-S in a stylized font. The letters are bold and black, and they appear to be slightly distorted. The background of the image is a pattern of small squares and lines. The overall effect is modern and abstract.
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
5
| 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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Mary S. Runner -S
Susan Runner DDS, MA 2014.02.21
09:42:24′-05'00' |
| ------------------------------------------------------------------------------ | -------------------------------------------------------------------------- |
|---|
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