COLLAGEN DENTAL MENBRANE - CONFORMABLE II

K062881 · Collagen Matrix, Inc. · NPL · Oct 11, 2006 · Dental

Device Facts

• Record ID: K062881
• Device Name: COLLAGEN DENTAL MENBRANE - CONFORMABLE II
• Applicant: Collagen Matrix, Inc.
• Product Code: NPL · Dental
• Decision Date: Oct 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Collagen Dental Membrane-Conformable II is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery.

Device Story

Collagen Dental Membrane-Conformable II is a white, nonfriable, resorbable membrane matrix derived from highly purified bovine Achilles tendon type I collagen. Designed for dental surgery, the membrane is flexible and conforms to the contours of defect sites. It is supplied sterile, non-pyrogenic, and for single-use. The device acts as a barrier or scaffold to aid in wound healing during dental implant, bone defect, or ridge reconstruction procedures. It is intended for use by dental surgeons in a clinical setting.

Clinical Evidence

Bench testing only. In vitro product characterization studies and biocompatibility testing per ISO 10993-1 and FDA Blue Book Memorandum G95-1 were performed to demonstrate safety and substantial equivalence.

Technological Characteristics

Resorbable membrane matrix; material: highly purified type I collagen from bovine Achilles tendon; form: flexible, nonfriable, conformable sheet; sterilization: sterile; single-use; non-pyrogenic.

Indications for Use

Indicated for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in 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.

Predicate Devices

• Collagen Dental Membrane (K011695)

Submission Summary (Full Text)

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

K062881

# 510(k) Summary of Safety and Effectiveness

# OCT 1 1 2006

| Applicant Name and Address: Collagen Matrix, Inc. | 509 Commerce Street<br>Franklin Lakes, New Jersey 07417 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC<br>Sr. Director, Clinical, Regulatory, and Quality Assurance<br>Tel: [phone]<br>Fax: [phone] |
| Date of Summary: | September 25, 2006 |
| Device Common Name: | Collagen Dental Membrane |
| Device Trade Name: | Collagen Dental Membrane - Conformable II |
| Device Classification Name: | Bone Grafting Material<br>Class II<br>872.3930<br>LYC |
| Predicate Device(s): | Collagen Dental Membrane, K011695 |

#### Description of the Device

Collagen Dental Membrane-Conformable II is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane-Conformable II is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

#### Intended Use

Collagen Dental Membrane-Conformable II is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery.

## Summary/Comparison of Technical Characteristics

Collagen Dental Membrane-Conformable II and its predicate have similar technological characteristics. In particular, the Collagen Dental Membrane-Conformable II and its predicate are similar with respect to intended use, material, form, sizes, thickness, physical integrity, permeability and conformability.

{1}------------------------------------------------

### Safety

A Collagen Dental Membrane-Conformable II equivalent has been evaluated by a I Contagen Domar Messa its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

### Conclusion

The results of the in vitro product characterization studies show that the device Firstitution of the Collagen Dental Membrane-Conformable II is safe and substantially equivalent to the original device.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

OCT 1 0 2007

Ms. Peggy Hansen Senior Director, Clinical, Regulatory and Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K062881

Trade Name: Collagen Dental Membrane-Conformable II Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: September 25, 2006 Received: September 27, 2006

Dear Ms. Hansen:

This letter corrects our substantially equivalent letter of October 11, 2006.

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 require apple 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.

{3}------------------------------------------------

#### Page 2 -

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 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]. 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 [phone] or [phone] or at its Internet address 1 http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Syrite Y. Michieoms.

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

Image /page/3/Picture/7 description: The image is a circular logo or emblem. The text "1906 - 2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are below the word "Centennial".

Protecting and Promoting Public Health

{4}------------------------------------------------

# Indications for Use

K062881

510(k) Number (if known):

Collagen Dental Membrane - Conformable II Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Collagen Dental Membrane – Conformable 11 is intended for use in oral surgical Collegon Donal resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Byrne

on Sign-Off) of Anesthesiology, General Hospital, . Non Control, Dental Devis

Number:

Page 1 of 1