MUCOGRAFT COLLAGEN MATRIX

K073711 · Ed. Geistlich Soehne AG Fuer Chemische Industrie · NPL · May 30, 2008 · Dental

Device Facts

• Record ID: K073711
• Device Name: MUCOGRAFT COLLAGEN MATRIX
• Applicant: Ed. Geistlich Soehne AG Fuer Chemische Industrie
• Product Code: NPL · Dental
• Decision Date: May 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MUCOGRAFT® Collagen Matrix is recommended for: Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; Covering of implants placed in immediate extraction sockets; Covering of implants placed in delayed extraction sockets; Localized ridge augmentation for later implantation; Alveolar ridge reconstruction for prosthetic treatment; Covering of bone defects after root resection, cystectomy, removal of retained teeth; Guided bone regeneration in dehiscence defects; and Guided tissue regeneration procedures in periodontal and recession defects.

Device Story

MUCOGRAFT® is a resorbable, bilayer collagen membrane derived from porcine peritoneum (smooth layer) and skin (porous layer). Used in dental surgery by clinicians to facilitate guided bone and tissue regeneration. The smooth, non-permeable outer layer acts as a barrier to prevent cell adhesion and protect the graft from oral trauma; the porous inner layer encourages cell invasion and stabilizes blood clots. The device is implanted at the surgical site to support healing and tissue growth. It is biodegradable and eliminates the need for secondary surgical removal. Benefits include improved handling, suturability, and promotion of bone/tissue regeneration in various dental defects.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, material characterization, and comparison to legally marketed predicate devices.

Technological Characteristics

Bilayer collagen membrane (Type I and III) from porcine source. Smooth layer (peritoneum) for barrier function; porous layer (skin) for cell infiltration. Sterilized via gamma irradiation. Dry thickness 2.5-5 mm; wet thickness ~1 mm. Non-crosslinked, non-chemically treated. Standalone implantable device.

Indications for Use

Indicated for dental patients requiring guided bone or tissue regeneration, including implant placement in extraction sockets, ridge augmentation, alveolar reconstruction, bone defect coverage (post-resection/cystectomy/tooth removal), and periodontal/recession 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

• MUCOGRAFT® (K012423 and K061244)
• BIO-GIDE® (K960724; K042197; and K050446)

Submission Summary (Full Text)

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## 510(k) Summary

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## MUCOGRAFT®

MAY 3 0 2008

#### SPONSOR 1.

Ed. Geistlich Soehne Ag für Chemische Industrie Geistlich Pharma Ag-Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND

Contact Person: Peter S. Reichertz, [phone] Date Prepared: May 22, 2008

#### 2. · DEVICE NAME

| Proprietary Name | MUCOGRAFT® Collagen Matrix |
|----------------------|------------------------------------------------------------------------|
| Common/Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone<br>Regeneration |
| Classification Name: | Barrier, Animal Source, Dental |

#### 3. PREDICATE DEVICES

MUCOGRAFT® (K012423 and K061244) BIO-GIDE® (K960724; K042197; and K050446)

#### 4. INTENDED USE

MUCOGRAFT® Collagen Matrix is recommended for:

- Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; ー
- ﺴﺘ Covering of implants placed in immediate extraction sockets;
- -Covering of implants placed in delayed extraction sockets:
- ー Localized ridge augmentation for later implantation:
- -Alveolar ridge reconstruction for prosthetic treatment;
- -Covering of bone defects after root resection, cystectomy, removal of retained teeth;
- . Guided bone regeneration in dehiscence defects; and
- Guided tissue regeneration procedures in periodontal and recession defects. -

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#### DEVICE DESCRIPTION 5.

MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.

#### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

MUCOGRAFT® collagen matrix is substantially equivalent to Geistlich's existing products MUCOGRAFT® resorbable bilayer membrane (K012423 and K061244) and BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration (subject to K960724; K042197; and K050446). The differences between the new product and the BIO-GIDE and MUCOGRAFT® products cleared previously via K061244 and K042197, respectively, are the following: (1) changes to the manufacturing process, including a change in the concentration and duration of the alkaline treatment step, a new freeze-dryer, and the solvent cleaning phase being performed earlier in the process; (2) a change in the blister material from polystyrene (PS) to amorphic polyethylene terephtalate (A-PET); (3) changes to the product specifications, including a parametric release for the Gamma-Sterilization, and the omission of certain release controls; (4) expanded indication for use in Guided Tissue Regeneration; (5) a new-layout for the product label and packaging; and (6) the thickness of membrane when dry is 2.5 mm to 5 mm as opposed to 2 mm with MUCOGRAFT® Resorbable Bilayer Membrane, but when wet and placed into a defect, both are approximate 1 mm. The proposed additional indication is for "guided tissue regeneration procedures in periodontal defects." Included by reference are all data submitted in the previous notification and clearance of BIO-GIDE® (K042197) and MUCOGRAFT® Resorbable Bilayer Membrane (K061244).

MUCOGRAFT®, like BIO-GIDE®, is a collagen membrane used in dental grafting, procedures. MUCOGRAFT® was previously determined to be substantially equivalent to BIO-GIDE® and is cleared for all of the indications for which BIO-GIDE® is cleared.

The following is a table comparing MUCOGRAFT® Collagen Matrix to MUCOGRAFT® Resorbable Bilayer Membrane for guided tissue and bone regeneration.

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## Table 1: MUCOGRAFT® Resorbable Bilayer Membrane (Predicate Device) vs. MUCOGRAFT® Collagen Matrix Comparison Chart

| | MUCOGRAFT® Resorbable<br>Bilayer Membrane | MUCOGRAFT®<br>Collagen Matrix |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for guided tissue<br>regeneration procedures in<br>periodontal defects to enhance<br>regeneration of the periodontal<br>apparatus. | Used for guided tissue<br>regeneration procedures in<br>periodontal defects to enhance<br>regeneration of the periodontal<br>apparatus. |
| Incorporates Same Basic Design | Yes | Yes |
| Utilizes Same Operating Principle | Cell occlusive<br>Implantable<br>Resorbable<br>Hemostatic | Cell occlusive<br>Implantable<br>Resorbable<br>Hemostatic |
| Incorporates Same Materials? | Yes, Type I and Type III<br>Collagen<br>Same Amount | Yes, Type I and Type III<br>Collagen<br>Same Amount |
| Sterilization Process | Gamma Irradiation | Gamma Irradiation |
| Biocompatible | Yes | Yes |
| Non-pyrogenic | Yes | Yes |
| Shelf Life | 36 Months | 36 Months |
| Thickness (dry) | Approx. 2 mm | Approx. 2.5-5 mm |
| Thickness (when placed over<br>defect) | Approx. 1 mm | Approx. 1 mm |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAY 3 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ed. Geistlich Soehne Ag Für Chemische Industrie C/O Mr. Peter S. Reichertz Sheppard, Mullin, Richter & Hampton LLP 1300 I Strect, N.W., 11th Floor East Washington, DC 20005

Re: K073711

Trade/Device Name: MUCOGRAFT® Collagen Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: May 22, 2008 Received: May 23, 2008

Dear Mr. Reichertz:

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 -- Mr. Reichertz

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 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 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/industry/support/index.html.

Sincerely yours,

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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# K073711

## Indications for Use

### 510(k) Number (if known): K073711

Device Name:

MUCOGRAFT® Collagen Matrix.

Indications for Use:

Simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; covering of implants placed in immediate extraction sockets; covering of implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; covering of bone defects after root resection; cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal and recession defects.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 801 Subpart C)

Susan Runore

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

510(k) Number.

K073711

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