KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX

K091192 · Kensey Nash Corp. · NPL · Nov 2, 2009 · Dental

Device Facts

• Record ID: K091192
• Device Name: KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
• Applicant: Kensey Nash Corp.
• Product Code: NPL · Dental
• Decision Date: Nov 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kensey Nash P1076 Collagen Dental Membrane is indicated for: - Simultaneous use of Guided Bone Regeneration (GBR)-membrane and implants. . - Augmentation around implants placed in immediate extraction sites. . - Augmentation around implants placed in delayed extraction sockets. . - Localized ridge augmentation for later implantation. . - Alveolar ridge reconstruction for prosthetic treatment. 9 - Filling of bone defects after root resection, cystectomy, removal of retained teeth. . - Guided bone regeneration in dehiscence defects. . - Guided tissue regeneration procedures in periodontal defects

Device Story

Resorbable, translucent, rectangular collagen membrane sheet derived from bovine tissue; intended for single-use in dental surgical procedures. Acts as barrier to facilitate guided bone and tissue regeneration. Used by dental clinicians in clinical settings. Sterilized via ethylene oxide. Provides physical scaffold to support bone healing and tissue regeneration around implants or in periodontal defects.

Clinical Evidence

Bench testing only.

Technological Characteristics

Bovine-derived collagen membrane; resorbable; rectangular sheet; sterilized via ethylene oxide.

Indications for Use

Indicated for patients requiring guided bone or tissue regeneration in dental procedures, including implant site augmentation (immediate/delayed), alveolar ridge reconstruction, and bone defect filling following root resection, cystectomy, or tooth extraction.

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

• Bio-Gide (K050466)
• Collagen Dental Membrane - Conformable II (K062881)

Submission Summary (Full Text)

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## 510(k) Summary

ensev Nash

NOV - 2 2009

Submitted by:

Kensey Nash Corporation 735 Pennsylvania Drive Exton, PA 19341

Contact Person:

Date Prepared:

510(K) #: Device:

Trade Name:

Alyssa J. Schwartz, MS, RAC Regulatory Affairs Specialist Ph: [phone] Fax: [phone]

April 17, 2009

Kensey Nash P1076 Collagen Dental Membrane Collagen Dental Membrane Barrier, Animal Source, Intraoral 21 CFR 872.3930, NPL, Class II

#### Device Description:

Common/Usual Name:

Proposed Classification:

The Kensey Nash (KN) P1076 Collagen Dental Membrane is a translucent, resorbable, rectangular collagen membrane sheet derived from bovine tissue. The KN P1076 Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.

#### Intended Use:

The Kensey Nash P1076 Collagen Dental Membrane is indicated for:

- Simultaneous use of Guided Bone Regeneration (GBR)-membrane and implants. .
- Augmentation around implants placed in immediate extraction sites. .
- Augmentation around implants placed in delayed extraction sockets. .
- Localized ridge augmentation for later implantation. .
- Alveolar ridge reconstruction for prosthetic treatment. 9
- Filling of bone defects after root resection, cystectomy, removal of retained teeth. .
- Guided bone regeneration in dehiscence defects. .
- Guided tissue regeneration procedures in periodontal defects .

| Predicate Devices: | | |
|-----------------------|-------------------------------------------|---------|
| Manufacturer | Device | 510(k)# |
| Geistlich Pharma AG | Bio-Gide | K050466 |
| Collagen Matrix, Inc. | Collagen Dental Membrane - Conformable II | K062881 |

#### Substantial Equivalence:

Performance Testing has confirmed that the Kensey Nash P1076 Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Ms. Alyssa J. Schwartz Regulatory Affairs Specialist Kensey Nash Corporation 735 Pennsylvania Drive -Exton, Pennsylvania 19341

NOV - 2 2009

Re: K091192

Trade/Device Name: Kensey Nash P1076 Collagen Dental Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: September 25, 2009 Received: September 28, 2009

Dear Ms. Schwartz:

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. Schwartz

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Wh for

Susan Runner, D.D.S., M.A. Acting Division 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 Statement

KO91192 510(k) Number:

Device Name:

Kensey Nash P1076 Collagen Dental Membrane

## Indications For Use:

The Kensey Nash P1076 Collagen Dental Membrane is indicated for:

- Simultaneous use of GBR-membrane and implants.
- Augmentation around implants placed in immediate extraction sites.
- Augmentation around implants placed in delayed extraction sockets.
- Localized ridge augmentation for later implantation.
- Alveolar ridge reconstruction for prosthetic treatment.
- Filling of bone defects after root resection, cystectomy, removal of retained teeth.
- Guided bone regeneration in dehiscence defects.
- Guided tissue regeneration procedures in periodontal defects

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

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Puno

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

510(k) Number: K091192

1-800-524-1984

KENSEY NASH CORPORATION, 735 PENNSYLVANIA DRIVE, EXTON, PA 19341 Page 30 of 331