COLLAGEN DENTAL MEMBRANE IV

K090216 · Collagen Matrix, Inc. · NPL · Sep 18, 2009 · Dental

Device Facts

• Record ID: K090216
• Device Name: COLLAGEN DENTAL MEMBRANE IV
• Applicant: Collagen Matrix, Inc.
• Product Code: NPL · Dental
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Device Story

Collagen Dental Membrane IV is a sterile, non-pyrogenic, resorbable membrane matrix derived from bovine dermis (Type I and III collagen). Used in oral surgery by dentists/oral surgeons to facilitate guided bone and tissue regeneration. The membrane acts as a physical barrier to prevent soft tissue ingrowth into bone defects, allowing bone regeneration. It is flexible, conformable to defect contours, and supplied in various sizes for single use. It provides a scaffold for healing in extraction sockets, ridge augmentation, and periodontal defects.

Clinical Evidence

No clinical data. Safety and effectiveness supported by in vitro product characterization and in vivo animal studies. Device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 biocompatibility testing.

Technological Characteristics

Material: Highly purified Type I and III collagen from bovine dermis. Form: Nonfriable, conformable, resorbable membrane. Sterilization: Sterile. Biocompatibility: Compliant with ISO 10993-1 and FDA G95-1.

Indications for Use

Indicated for patients undergoing oral surgical procedures requiring guided bone or tissue regeneration, including implant site augmentation, ridge reconstruction, and periodontal defect repair.

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 - Conformable II (K062881)
• Bio-Gide™ Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration (K050446)
• Tutodent® Dental Membrane CopiOs™ Pericardium Membrane (K073097)

Submission Summary (Full Text)

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SEP 1 8 2009

### 510(k) Summary of Safety and Effectiveness

Applicant Name and Address: Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Contact Person:

Peggy Hansen, RAC Vice President, Clinical, Regulatory, QA, and Marketing Tel: [phone] Fax: [phone]

Date of Summary:

May 1, 2009

Device Common Name:

Device Trade Name:

Device Classification Name:

Barrier, animal source, intraoral 872.3930 NPL Class II

Resorbable Collagen Membrane

Collagen Dental Membrane IV

Predicate Device(s):

Collagen Dental Membrane - Conformable II K062881

Bio-Gide™ Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration K050446

Tutodent® Dental Membrane CopiOs™ Pericardium Membrane K073097

## Description of the Device

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

### Intended Use

Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later

implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

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### Summary/Comparison of Technical Characteristics

Collagen Dental Membrane IV and its predicates have similar technological characteristics. In particular, the Collagen Dental Membrane IV and its predicate are similar with respect to intended use, form, animal source, sizes, thickness, physical integrity, permeability and conformability.

### Safety

Collagen Dental Membrane IV has been evaluated in a number of in vitro and in vivo tests to assess 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 and in vivo animal studies show that Collagen Dental Membrane IV is safe and substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002

# SEP 1 8 2009

Ms. Peggy Hansen Vice President, Clinical, Regulatory Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersev 07417

Re: K090216

Trade/Device Name: Collagen Dental Membrane IV Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: September 4, 2009 Received: September 9, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting 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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K090216

## Indications for Use

510(k) Number (if known): K090216

Device Name: Collagen Dental Membrane IV

Indications for Use:

Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

### 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)

Kein Mulvey for MSP

Division Sign-Off) nivision of Anesthesiology, General Hospital niection Control, Dental Devices

-10(k) Number: K090216

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