Augmentation or reconstructive treatment of the alveolar ridge.
Filling of infrabony periodontal defects.
Filling of defects after root resection, apicoectorny, and cystectomy.
Filling of extraction sockets to enhance preservation of the alveolar ridge.
Elevation of the maxillary sinus floor.
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration and Guided Bone Regeneration.
Filling of perio-implant defects in conjunction with products intended for Guided Bone Regeneration.

Device Description

ODONCER is an osseo-conductive powder implant made of synthetic beta tricalcium phosphate (β-ΤCP (Cα3(PO4)2) indicated for bone grafting in dental applications.

AI/ML Overview

This submission for ODONCER Bone Grafting Material (K062102) is a 510(k) premarket notification. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, based on the provided document, the following sections cannot be fully populated as they pertain to performance testing and studies which are not characteristic of this type of submission.

Here's the information that can be extracted and a clear indication of why other information is not present:

No Acceptance Criteria or Device Performance Table

The provided 510(k) summary (K062102) establishes substantial equivalence for the ODONCER Bone Grafting Material. This type of submission does not typically involve defining specific acceptance criteria for performance or reporting device performance in the manner of a clinical study. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The summary states: "ODONCER does not incorporate any new technological characteristics as compared to the predicate devices. ODONCER and the predicate devices are made from the same material (pure-phase P-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade B-TCP to be used in surgical implant applications. ODONCER is substantially equivalent to the predicate devices in regard to structure, porosity, form, packaging, sterility, and biocompatibility."

This indicates that the "acceptance criteria" are effectively the characteristics and safety/performance profile of the predicate devices and adherence to relevant material standards (ASTM F1088-04).

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

As explained above, this submission focuses on substantial equivalence rather than reporting specific performance metrics against defined acceptance criteria from a clinical study. The "performance" is considered equivalent to the predicate devices due to shared material and characteristics.

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

Not applicable. No separate "test set" for performance evaluation in a clinical study is described within this 510(k) summary. The submission relies on non-clinical data and comparison to predicate devices, not human or large-scale animal testing that would involve a "test set" in the context of device performance metrics.

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)

Not applicable. No "ground truth" was established for a test set regarding device performance in the context of this 510(k) summary. The ground truth for safety and effectiveness is assumed to be established by the predicate devices.

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

Not applicable. No adjudication method for a test set is described.

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

Not applicable. This is a bone graft material, not an imaging device or an AI-assisted device. Therefore, MRMC studies and AI-related metrics are irrelevant.

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

Not applicable. This is a bone graft material, not an algorithm-based device.

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

For a 510(k) submission like this, the "ground truth" for demonstrating safety and effectiveness relies on:

Established performance and safety of legally marketed predicate devices.
Adherence to recognized standards: Specifically, ASTM F1088-04 for medical grade B-TCP.
Nonclinical tests: The summary mentions "Summary Nonclinical Tests" addressing structure, porosity, form, packaging, sterility, and biocompatibility, implying these were evaluated to ensure similarity to predicates and compliance with standards.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k) submission for a bone graft material.

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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

Koba102

510(k) Summary ODONCER Bone Grafting Material

Date March 30, 2007

Submitter TEKNIMED, SA 11 rue Apollo 31240 L'Union FRANCE

Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Trade Name ODONCER

Bone Grafting Material Common name

Classification name Bone grafting material for dental bone repair Class II per 21 CFR section 888.3045

Product Code LPK

Equivalent Device OSSAPLAST Dental (K053374) (OssascurAG) CALC-I-OSS (K042583) (Ultradent Products) Cerasob M Dental (K051443) (Curasan AG)

Device Description

ODONCER is an osseo-conductive powder implant made of synthetic beta tricalcium phosphate (β-ΤCP (Cα3(PO4)2) indicated for bone grafting in dental applications.

Intended Use

ODONCER Bone Grafting Material is recommended for:

Augmentation or reconstructive treatment of the alveolar ridge. .
Filling of infrabony periodontal defects. ●
Filling of defects after root resection, apicoectorny, and cystectomy. ●
Fillina of extraction sockets to enhance preservation of the alveolar ridge. .
Elevation of the maxillary sinus floor. .
Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration and Guided Bone Regeneration.
Filling of perio-implant defects in conjunction with products intended for Guided . Bone Regeneration.

Summary Nonclinical Tests

ODONCER does not incorporate any new technological characteristics as compared to the predicate devices. ODONCER and the predicate devices are made from the same material (pure-phase P-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade B-TCP to be used in surgical implant applications. ODONCER is substantially equivalent to the predicate devices in regard to structure, porosity, form, packaging, sterility, and biocompatibility.

APR 16 2007

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.

SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Teknimed SA C/O Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K062102

Trade/Device Name: ODONCER Bone Grafting Material Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: March 30, 2007 Received: April 2, 2007

Dear Mr. Webb:

This letter corrects our substantially equivalent letter of April 16, 2007.

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 (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.

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. Webb

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 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 (http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.D.

Chiu 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: ODONCER Bone Grafting Material

Indications for Use:

ODONCER Bone Grafting Material is recommended for:

Augmentation or reconstructive treatment of the alveolar ridge. .
Filling of infrabony periodontal defects.
. Filling of Intrabony penodoman acrosis.
Filling of defects after root resection, apicoector of the alveolar i
. Filling of defects arrer roof resection, aplesseremy of the alveolar ridge.
Filling of extraction sockets to el hance preservation of the alveolar ridge.
. Elevation of the maxillary sinus floor.
Elevation of the maxiliary shus lioon.
Filling of periodontal defects in conjunction with products intended for
clinity of periodontal defects in conjunction with products in .
◆ Filling of periodonial delects in conjuned bone Regeneration.
Guided Tissue Regeneration and Guided Bone Regeneration
Guided lissue Regeneration and Octubed bone help of the . Guided Bone Regeneration.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Pearce

of Anacinatiology, Cameral Hospital, Jon Control, Deman Devices

2(k) Number: K62102

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.