OTA COLLAGEN BIOMATERIAL

K073685 · Osseous Technologies of America · NPL · Aug 29, 2008 · Dental

Device Facts

• Record ID: K073685
• Device Name: OTA COLLAGEN BIOMATERIAL
• Applicant: Osseous Technologies of America
• Product Code: NPL · Dental
• Decision Date: Aug 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.

Device Story

OTA Collagen Biomaterial is a resorbable, biocompatible membrane matrix derived from bovine Achilles tendon type I collagen. Used in dental surgery, the device is applied by a clinician to cover defects or contain bone grafts. The porous material is flexible when moistened with water, saline, serum, or blood, allowing it to conform to the surgical site. It is cut to size by the surgeon as needed. The device acts as a barrier to aid in wound healing post-procedure. It is provided sterile for single use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Resorbable membrane matrix; material: highly purified type I collagen from bovine Achilles tendon; form factor: porous, flexible sheet available in various shapes/sizes; sterilization: sterile for single use.

Indications for Use

Indicated for patients undergoing dental surgery requiring a resorbable barrier for dental implants, bone defects, or ridge reconstruction to support wound healing.

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.

Submission Summary (Full Text)

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K073685

OTA Collagen Biomaterial

# 510(k) Summary

#### Osseous Technologies of America, Inc. AIG 29 2008 OTA Collagen Biomaterial

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Osseous Technologies of America, Inc.<br>4500 Campus Drive, Suite 662<br>Newport Beach, CA 92660<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Janet May, Director of Operations |
| Representative/Consultant: | David J. Collette, MD or<br>Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA USA 92130<br>Telephone: [phone]<br>Fax: [phone] |

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations: Product Code: Classification Panel: Reviewing Branch:

OTA Collagen Biomaterial Collagen dental membrane Barrier, Animal Source, Intraoral, Class II, Unclassified NPL Dental Products Panel Dental Devices Branch

Email: [e-mail]

[e-mail]

#### INTENDED USE

OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.

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510(k) Summary

K073685

OTA Collagen Biomaterial

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### DEVICE DESCRIPTION

OTA Collagen Biomaterial is an off-white, biocompatible, non-friable, resorbable membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. When moistened with water, saline, serum or blood, the porous material is flexible and conforms to the contours of the defect site. The material is easily cut with scissors or scalpel to meet the needs of the surgeon. OTA Collagen Biomaterial is non-pyrogenic and is provided sterile for single use only.

OTA Collagen Biomaterial is available in four shapes and a number of sizes. It can be applied as an onlay to cover simple defects or can be used for bone graft containment.

### EQUIVALENCE TO MARKETED PRODUCT

Osseous Technologies of America, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, OTA Collagen Biomaterial is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

OTA Collagen Biomaterial has the following similarities to the predicate devices:

- has the same intended use. 트
- uses the same operating principle,
- 트 incorporates the same basic design,
- 트 incorporates the same materials, and
- 트 is sterilized using the same process.

In summary, OTA Collagen Biomaterial is, in our opinion, substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 2 9 2008

Osseous Technologies of America C/O Dr. David J. Collette Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K073685

Trade/Device Names: OTA Collagen Biomaterial Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: August 21, 2008 Received: August 22, 2008

Dear Dr. Collette:

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.

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 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 - Dr. Collette

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Susan Rummo
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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510(k) Premarket Notification

K073685

OTA Collagen Biomaterial

## Indications for Use

510(k) Number (if known):

Device Name: OTA Collagen Biomaterial

Indications for Use:

OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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) | |
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| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
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| 510(k) Number: | RC73685 |