ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)

K955838 · Atrix Laboratories, Inc. · NPK · Mar 21, 1996 · Dental

Device Facts

• Record ID: K955838
• Device Name: ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)
• Applicant: Atrix Laboratories, Inc.
• Product Code: NPK · Dental
• Decision Date: Mar 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit is a medical device intended for use in dental procedures to facilitate guided tissue regeneration. The device functions as a barrier to prevent soft tissue ingrowth into bone defects, allowing for bone regeneration. It is applied by dental professionals in a clinical setting. The barrier is bioabsorbable, eliminating the need for a second surgical procedure for removal. By isolating the defect site, it promotes the healing of periodontal tissues.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) notification.

Technological Characteristics

Bioabsorbable barrier material; designed for guided tissue regeneration; classified under 21 CFR 872.3930 as a bone grafting 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville, Maryland 20850

Elaine M. Gazdeck, R.A.C.
Director, Regulatory Affairs
Atrix Laboratories, Incorporated
2579 Midpoint Drive
Fort Collins, Colorado 80525-4417

Re: K955838
Trade Name: Atrisorb® Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit
Regulation Number: 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: 2
Product Code: NPK
Dated: December 21, 1995
Received: December 22, 1995

Dear Ms. Gazdeck:

This letter corrects our substantially equivalent letter of March 21, 1996.

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

Sincerely yours,

*Dwight Y. Michaud* m.d.

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


*Protecting and Promoting Public Health*