COLLAGEN DENTAL WOUND DRESSINGS

K033729 · Collagen Matrix, Inc. · LYC · Mar 17, 2004 · Dental

Device Facts

• Record ID: K033729
• Device Name: COLLAGEN DENTAL WOUND DRESSINGS
• Applicant: Collagen Matrix, Inc.
• Product Code: LYC · Dental
• Decision Date: Mar 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Collagen Dental Sponge Membranes are intended for use in patients with moderate to periodontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.

Device Story

Collagen Dental Sponge Membrane is a resorbable, sterile, non-pyrogenic, single-use device manufactured from crosslinked type I collagen derived from bovine Achilles tendon. It is intended for placement in periodontal defects by dental professionals during periodontal surgery to facilitate wound healing. The device acts as a scaffold or barrier material. It is supplied in a sponge form factor.

Clinical Evidence

Bench testing only; device passed all applicable ISO 10993-1 testing for biological evaluation.

Technological Characteristics

Material: Crosslinked type I collagen derived from bovine Achilles tendon. Form factor: Sponge. Sterilization: Sterile. Single-use. Biocompatibility: Compliant with ISO 10993-1.

Indications for Use

Indicated for patients with moderate to periodontal disease requiring a resorbable material for placement in periodontal defects to aid in wound healing following periodontal surgery.

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)
• Collagen Periodontal Membrane (K003339)

Submission Summary (Full Text)

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MAR 1 7 2004

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# 510(k) Summary of Safety and Effectiveness

| Applicant Name and Address: Collagen Matrix, Inc. | 509 Commerce Street<br>Franklin Lakes, New Jersey 07417 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC<br>Director, Clinical, Regulatory, and Quality Assurance<br>Tel: [phone]<br>Fax: [phone] |
| Date of Summary: | March 11, 2004 |
| Device Common Name: | Collagen Dental Sponge Membranes |
| Device Trade Name: | To be determined |
| Device Classification Name: | Bone filling augmentation material<br>Unclassified<br>LYC |
| Predicate Device(s): | Collagen Dental Membrane, K011695<br>Collagen Periodontal Membrane, K003339 |

## Description of the Device

Description of the Dore." Conagen Domar Sponge recemsnufactured from crosslinked type I collagen derived from bovine Achilles tendon. The product is supplied sterile, non-pyrogenic, and for single use only.

## Indications for Use

Thurculous for 'Co Conagen Donal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.

## Summary/Comparison of Technical Characteristics

Sullagen Dental Sponge Membranes and its predicates have similar technological characteristics. In particular, the Collagen Dental Sponge Membranes and their enaracteristics. In particles pect to intended use, material, source, sterilization, etc.

#### Safety

Collagen Dental Sponge Membranes have been evaluated by a number of tests to assess Conagen Doman oponge .ye. The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices.

## Conclusion

Conclusion The results of the will of the Sponge Membranes are safe and substantially equivalent to its predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2004

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

Re: K033729

Trade/Device Name: Collagen Dental Sponge Membrane Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: January 26, 2004 Received: January 27, 2004

Dear Ms. Hansen:

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 -Ms. Hansen

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 [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 http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

foc

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): ____K033729

Collagen Dental Sponge Membranes Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Collagen Dental Sponge Membranes are intended for use in patients with moderate to Sollagen Bontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.

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)

follwutrhh

sion Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

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510(k) Number: K033729