The T.B.R.® ide@ conic endosseous dental implant is a device 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, and to restore the patient's chewing function.

Device Description

Description of the donic/Conic dental implant system consists of selftapping threaded screw-type implants (made from Ti-6AI-4V ) and tapping througou overs with many options such as Ti-6Al-4V abutments, tapered abutments, castable abutments, ball abutments and ceramic/Titapered abutments. The system also include surgical and laboratory ord av abutiments. Implants are double-packaged and provided sterile. Implants surface is roughened to promote osseointegration.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (T.B.R.® ide@ conic endosseous dental implant) and does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML algorithm.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on:

Mechanical testing: This was done in accordance with FDA guidance for root-form endosseous dental implants and abutments. It showed "sufficient mechanical static and dynamic strength."
Biocompatibility testing: Conclusions demonstrate the safety and effectiveness of the implant system.
Technological characteristics: A comparison table is provided highlighting similarities in type, lengths, diameters, connection, shape, materials, and surface with predicate devices.

Therefore, I cannot provide the requested information for an AI/ML device's acceptance criteria and study, as the input document describes a traditional medical device (dental implant).

The following information cannot be extracted from the provided document as it pertains to a traditional medical device submission, not an AI/ML device:

A table of acceptance criteria and the reported device performance (for an AI/ML algorithm).
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

Summary

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K050956

FEB 1 6 2006

510(k) Summary

Sudimplant, SA Submitter: Parc de la Plaine 24, impasse René Couzinet 31500 Toulouse, FRANCE Tel: +335 62 16 71 00 Fax: +335 61 80 84 02
Mr. Didier Sailhan Contact: Requlatory Affairs Manager E-mail: production@tbridea.com

June 22, 2005 Date:

Device Name: T.B.R.6 ide@ conic

Endosseous dental implant (21 CFR Classification Name: 872.3640) and Endosseous dental implant abutment (21 CFR 872.3630)

Legally marketed device (predicate devices):

3i Osseotite Certain NT (K031475) u
Bio-Lok Silhouette & Silhouette IC (K032454) L
Zimmer Dental (formerly Sulzer Dental) Tapered Screw-Vent 트 (K013227, K011028)

Description of the device:

Intended use:

The T.B.R.® ide@ conic endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to to be ourglean; prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Summary of testing:

Mechanical testing was done in accordance with the FDA guidance "Class Mechaniour controls guidance document:Root-form endosseous dental implants and endosseous dental abutments" issued on May 12, 2004. Implans and ondessendent laboratory showed T.B.R.R.® ide@ conic to have sufficient mechanical static and dynamic strength. Additionnal test

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report include biocompatibility testing. Test conclusions demonstrate the report include blocompatistiky tooling."
safety and effectiveness of T.B.R.® ide@ conic implant system.

Technological characteristics:

The overall design and characteristics of the T.B.R.® ide@ conic/Conic The overall design and charactoriotics of the and as safe, as effective implants are similar to the production as nowledgedly predicate devices.

	New device	Predicate Devices
		Bio-LokSilhouette	ZimmerTaperedScrew-Vent	3iOsseotiteCertain NT
	Conic
510(k) number		K032454	K013227 K011028	K031475
Type	Self-TappingThreadedScrew	Self-TappingThreadedScrew	Self-TappingThreadedScrew	Self-TappingThreadedScrew
Lengths (mm)	8-15,5	8-15	8-16	8,5-15
Diameters (mm)	3,5-5	3,45-6,5	3,5-5,7	3,25-6
Connection	InternalOctagon	InternalConnection orExternalhexagon	InternalHexagon	InternalHexagon
Shape	Tapered	Tapered	Tapered	Tapered
Materials	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V
Surface	Sandblasted/Acid-etched	Osseo-LokHA-coatedLaser-Lok	Machined /blasted-etchedMachined/HA	Acid-etched
Sterility	Gamma	Unknown	Unknown	Gamma
Abutmentcontainingceramic	Available	Available	No	No

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.

FEB 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Didier Sailhan Regulatory Affairs Manager Sudimplant SA 24 Impasse Rene Couzinet Parc De La Plaine Toulouse, France 31500

Re: K050956

Trade/Device Name: T.B.R.® ide@-conic Regulation Number: 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: January 20, 2006 Received: January 20, 2006

Dear Ms. Sailhan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becater mined the device is substantially equivalent (for the icitications 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 microlie conments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de rous that the Act (Act) that do not require approval of a premarket the Federal F ood, Drag, the Commay, therefore, market the device, subject to the general approvincianon (Printers) (The general controls provisions of the Act include controls provisions or annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 MA), it may of subject to back add of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the over announcements concerning your device in the Federal Register.

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Page 2 - Ms. Didier Sailhan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sengate Y. Michie Davis

Chíu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: T.B.R.® ide@ conic

Indications For Use:

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

Susan Quares

Case Cit

KCB50756

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.