MUCOGRAFT

K012423 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · NPL · Jan 24, 2003 · Dental

Device Facts

• Record ID: K012423
• Device Name: MUCOGRAFT
• Applicant: Ed. Geistlich Soehne AG Fuer Chemische Industrie
• Product Code: NPL · Dental
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MUCOGRAFT® is indicated for: - simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; - - augmentation around implants placed in immediate extraction sockets; - - 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.

Device Story

MUCOGRAFT is a membrane used for guided bone regeneration (GBR) in dental surgery. It acts as a barrier to facilitate bone tissue growth in localized ridge augmentation, alveolar ridge reconstruction, and bone defect filling (e.g., post-extraction or cystectomy). Used by dental surgeons in clinical settings; the device is placed over bone defects to prevent soft tissue ingrowth, allowing bone regeneration. It supports implant procedures by providing a stable environment for bone formation. Benefits include improved ridge architecture for prosthetic treatment and successful implant integration.

Clinical Evidence

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

Technological Characteristics

Bone grafting material/membrane for guided bone regeneration. Class II device (Product Code: NPL).

Indications for Use

Indicated for patients requiring guided bone regeneration (GBR) and alveolar ridge augmentation in dental procedures, including implant placement (immediate/delayed), 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

Ed. Geistlich Sohne Ag Fur Chemische Industre C/O Mr. Peter S. Reichertz Official Correspondent Arent Fox Kinter Plotkin & Kahn PLLC 1050 Connecticut Avenue Washington, D.C. 20036

Re: K012423

Trade Name: MUCOGRAFT Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: November 25, 2002 Received: November 26, 2002

Dear Mr. Reichertz:

This letter corrects our substantially equivalent letter of January 24, 2003.

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,

Snytte Y. Michie Dmd.

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

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Protesting and Promoting Public Health

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K012423

Attachment #1

## Indications for Use Form

Page 1 of 1

510(k) Number (if known): K012423

Device Name: MUCOGRAFT

Indications for Use:

## INDICATIONS:

MUCOGRAFT® is indicated for:

- simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; -
- augmentation around implants placed in immediate extraction sockets; -
- 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. ﺖ

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Kevin Mulry for WSR

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

510(k) Number: K012423