ODONCER

K062102 · Teknimed, S.A. · LYC · Apr 16, 2007 · Dental

Device Facts

• Record ID: K062102
• Device Name: ODONCER
• Applicant: Teknimed, S.A.
• Product Code: LYC · Dental
• Decision Date: Apr 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

ODONCER is a synthetic beta-tricalcium phosphate (β-TCP) powder implant used as an osseo-conductive bone grafting material in dental procedures. It is applied by dental professionals to fill bone defects or augment the alveolar ridge. The material acts as a scaffold to support bone regeneration. It is supplied as a sterile powder. The device is used in a clinical dental setting to facilitate bone repair, potentially improving outcomes for patients requiring dental implants or periodontal treatment.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Synthetic beta-tricalcium phosphate (β-TCP) powder. Conforms to ASTM F1088-04. Osseo-conductive material. Sterile, powder form factor.

Indications for Use

Indicated for dental bone repair, including alveolar ridge augmentation/reconstruction, filling of infrabony periodontal defects, defects post-root resection/apicoectomy/cystectomy, extraction sockets for ridge preservation, maxillary sinus floor elevation, and perio-implant defects in conjunction with GTR/GBR products.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OSSAPLAST Dental (K053374)
• CALC-I-OSS (K042583)
• Cerasob M Dental (K051443)

Submission Summary (Full Text)

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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 [phone] (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 [phone] or [phone] 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