DYNAMATRIX

K082058 · Cook Biotech, Inc. · NPL · Oct 2, 2008 · Dental

Device Facts

• Record ID: K082058
• Device Name: DYNAMATRIX
• Applicant: Cook Biotech, Inc.
• Product Code: NPL · Dental
• Decision Date: Oct 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.

Device Story

DynaMatrix is a bioabsorbable, extracellular collagen membrane matrix. It functions as a physical barrier to aid in guided tissue and bone regeneration procedures by containing graft material and preventing its migration. The device is provided sterile for one-time use in dental/periodontal applications. It is identical in design and material to the predicate SURGISIS Periodontal Membrane. The device is applied by a clinician during surgical procedures to support healing of periodontal defects or alveolar ridge augmentation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical design and material composition to the predicate device.

Technological Characteristics

Bioabsorbable extracellular collagen membrane matrix. Identical to predicate SURGISIS Periodontal Membrane. Sterile, single-use.

Indications for Use

Indicated for patients requiring guided tissue or bone regeneration, including healing of periodontal defects, gingival augmentation, alveolar ridge maintenance/enhancement, and containment of graft material.

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

• SURGISIS® Periodontal Membrane (K010952)

Submission Summary (Full Text)

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510(k) Summary

K082058
510(k) Summary

DynaMatrix™M

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# Cook Biotech Incorporated DynaMatrix

OCT 02 2008

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Cook Biotech Incorporated<br>1425 Innovation Place<br>West Lafayette, Indiana 47906<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Perry W. Guinn |
| Representative/Consultant: | David Collette, M.D.<br>Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130<br>Telephone: [phone]<br>Fax: [phone]<br>email: [e-mail]<br>[e-mail] |

### DEVICE NAME AND CLASSIFICATION

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

DynaMatrix™ Barrier, animal source, intraoral Class II, 21 CFR 872.3930 NPL Dental Products Panel Dental Devices Branch

#### INTENDED USE

DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.

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510(k) Summary

K082058

DynaMatrix™

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## DEVICE DESCRIPTION

DynaMatrix™ is a bioabsorbable, extracellular collagen membrane matrix that is identical to the predicate SURGISIS® Periodontal Membrane (K010952), also manufactured by Cook Biotech Incorporated. This premarket notification is being submitted to expand the indications for use and to introduce a new product name.

### EQUIVALENCE TO MARKETED DEVICE

Cook Biotech Incorporated demonstrated that, for the purposes of FDA's regulation of medical devices, DynaMatrix 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 02 2008

Cook Biotech, Incorporated C/O Dr. David J. Collette Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K082058

Trade/Device Name: DynaMatrixTM Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: September 26, 2008 Received: September 29, 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 (OS) 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 vours.

J.K. Mueller, M.D. for U

Chiu S. Lin. Ph. D 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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510(k) Premarket Notification

DynaMatrix™

1071

# Indications for Use

K082058

510(k) Number (if known): K082058

Device Name: DynaMatrix TM

Indications for Use:

DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bonc regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or cnhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.

Susan Rooney

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

510(k) Number: K052258

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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