OSSIX -PLUS

K053260 · Colbar Lifescience , Ltd. · NPL · Feb 22, 2006 · Dental

Device Facts

• Record ID: K053260
• Device Name: OSSIX -PLUS
• Applicant: Colbar Lifescience , Ltd.
• Product Code: NPL · Dental
• Decision Date: Feb 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ossix™-Plus biodegradable collagen membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: - Ridge augmentation for later implant insertions. . - Simultaneous ridge augmentation and implant insertions. . - Ridge augmentation around implants inserted in delayed extraction sites. . - Ridge augmentation around implants inserted in immediate extraction . sites. - Alveolar ridge preservation consequent to tooth (teeth) extraction(s). . - Over the window in lateral window sinus elevation procedures. . - In implants with vertical bone loss due to infection, only in cases where . satisfactory debridment and implant surface disinfection can be achieved. - In intra bony defects around teeth . - For treatment of recession defects, together with coronally positioned flap . - In furcation defects in multi rooted teeth .

Device Story

Ossix-Plus is a resorbable dental barrier membrane derived from porcine collagen; cross-linked with ribose. Device functions as a physical barrier to segregate gingival connective tissue and epithelium from bony or periodontal defects; creates a protected space for bone-forming cells to migrate and regenerate bone/periodontal structures. Applied by dental clinicians during surgical procedures (e.g., implant placement, ridge augmentation). Membrane resorbs naturally within approximately 8 months; eliminates need for second surgical removal procedure. Benefits include guided tissue regeneration (GTR) and guided bone regeneration (GBR) to support dental implants and treat periodontal defects.

Clinical Evidence

Bench testing and animal model alveolar defect testing were conducted. Animal studies demonstrated the device functions as a resorbable barrier membrane for guided bone regeneration and supports the specified dental indications. No human clinical trial data provided.

Technological Characteristics

Resorbable dental membrane composed of ribose cross-linked porcine collagen. Functions as a physical barrier for tissue segregation. Resorption time is approximately 8 months. Non-mechanical, non-electronic device.

Indications for Use

Indicated for patients requiring guided bone or tissue regeneration in dental procedures, including ridge augmentation, alveolar ridge preservation, sinus elevation, and treatment of periodontal defects (recession, furcation, or intra-bony). Contraindicated in cases where satisfactory debridement and implant surface disinfection cannot be achieved for infected sites.

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

• ColBar LifeScience Ltd. - Bio-Bar
• Geistlich Pharma's Bio-Gide Resorbable Bilayer Membrane

Submission Summary (Full Text)

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FEB 2 2 2006

K053260

#### V. 510(K) SUMMARY

# ColBar LifeScience Ltd.'s Ossix'M-Plus

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

ColBar LifeScience Ltd. 9 Hamenofim St. P.O. Box 12206, Herzliya, 46733, Israel

Tel: [phone] Fax: [phone]

Contact Person: Orit Tal-Shmayovits, Director of Regulatory Affairs

November 21, 2005 Date Prepared:

### Name of Device and Name/Address of Sponsor

Ossix™ Plus

ColBar LifeScience Ltd. 9 Hamenofim St. P.O. Box 12206, Herzliya, 46733, Israel

### Common or Usual Name

Resorbable dental barrier membrane, animal source

#### Classification Name

N/A, unclassified device

#### Predicate Devices

ColBar LifeScience Ltd. - Bio-Bar Geistlich Pharma's Bio-Gide Resorbable Bilayer Membrane

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K053260

# Intended Use / Indications for Use

Ossix™-Plus biodegradable collagen membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

- Ridge augmentation for later implant insertions. .
- Simultaneous ridge augmentation and implant insertions. .
- Ridge augmentation around implants inserted in delayed extraction sites. .
- Ridge augmentation around implants inserted in immediate extraction . sites.
- Alveolar ridge preservation consequent to tooth (teeth) extraction(s). .
- Over the window in lateral window sinus elevation procedures. .
- In implants with vertical bone loss due to infection, only in cases where . satisfactory debridment and implant surface disinfection can be achieved.
- In intra bony defects around teeth .
- For treatment of recession defects, together with coronally positioned flap .
- In furcation defects in multi rooted teeth .

#### Technological Characteristics

Ossix-Plus is a resorbable dental membrane made from ribose cross-linked porcine collagen. The membrane provides a barrier that guides bone regeneration, segregates tissue layers, or supports periodontal tissue regeneration. Barrier membranes are placed over bony or periodontal defects to prevent the population by cells from the gingival connective tissue and epithelium. This segregation of tissues by the membrane creates a cavity into which bone forming cells migrate and leads to new bone formation, as well as allowing cementum with inserting periodontal fibers to reform on exposed roots. The regeneration of lost periodontal structures (bone, periodontal ligament, and connective tissue attachment) around teeth is known as guided tissue regeneration ("GTR").

Because Ossix-Plus is a collagen membrane of animal origin, the device resorbs over time (within approximately 8 months based on animal model data). A second surgical procedure to remove the membrane is not required.

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### Performance Data

To assess the performance of Ossix-Plus, ColBar conducted animal model alveolar defect testing. The conducted tests demonstrated that Ossix-Plus functions as a resorbable barrier membrane in guided bone regeneration. Oral applications, including:

- Ridge augmentation for later implant insertions. .
- Simultaneous ridge augmentation and implant insertions. .
- Ridge augmentation around implants inserted in delayed extraction sites. .
- Ridge augmentation around implants inserted in immediate extraction . sites.
- Alveolar ridge preservation consequent to tooth (teeth) extraction(s). .
- Over the window in lateral window sinus elevation procedures. .
- In implants with vertical bone loss due to infection, only in cases where . satisfactory debridment and implant surface disinfection can be achieved.

## Substantial Equivalence

Ossix-Plus is as safe and effective as the Ossix™ and Bio-Gide. The Ossix-Plus has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ossix-Plus and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Ossix-Plus is as safe and effective as predicate devices. Thus, Ossix-Plus is substantially equivalent.

7

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three heads, with the heads stacked on top of each other. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" written around it.

OCT 1 0 2007

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

Colbar Lifescience Limited C/O Mr. Jonathan S. Kahan Hogan & Hartson LLP 555 Thirteenth Street, NW Washington, DC 2004

Re: K053260

Trade Name: Ossix-Plus Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: February 16, 2006 Received: February 16, 2006

Dear Mr. Kahan:

This letter corrects our substantially equivalent letter of February 22, 2006

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,

Sprite K. 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

Image /page/4/Picture/7 description: The image is a circular seal with the text "1906-2006 FDA Centennial" in the center. The seal also contains the text "PROTECTING AND PROMOTING YOUR HEALTH" around the perimeter. There are three stars below the word "Centennial". The seal appears to commemorate the 100th anniversary of the Food and Drug Administration (FDA).

Protecting and Promoting Public Health

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K053260

#### IV. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Ossix™-Plus

#### Indications for Use:

Ossix™-PLUS biodegradable collagen membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for:

- Ridge augmentation for later implant insertions. .
- . Simultaneous ridge augmentation and implant insertions.
- Ridge augmentation around implants inserted in delayed extraction sites. .
- . Ridge augmentation around implants inserted in immediate extraction sites.
- Alveolar ridge preservation consequent to tooth (teeth) extraction(s). .
- . Over the window in lateral window sinus elevation procedures.
- In implants with vertical bone loss due to infection, only in cases where . satisfactory debridment and implant surface disinfection can be achieved.
- . In intra bony defects around teeth
- For treatment of recession defects, together with coronally positioned flap
- In furcation defects in multi rooted teeth

| Prescription Use _X_ | AND/OR | Over-The-Counter Use _ |
|--------------------------------|--------|---------------------------|
| (Part 21 C.F.R. 801 Subpart D) | | (21 C.F.R. 807 Subpart C) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Sara Ruosses

17 Seneral Huspit 1

05 3246

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