BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN

K033815 · Geistlich-Pharma · NPM · Jan 15, 2004 · Dental

Device Facts

• Record ID: K033815
• Device Name: BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
• Applicant: Geistlich-Pharma
• Product Code: NPM · Dental
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BIO-OSS®, BIO-OSS Blocks and BIO-OSS® Collagen are recommended for: . Filling of large oral and maxillofacial intra-osseous cavities

Device Story

BIO-OSS, BIO-OSS Blocks, and BIO-OSS Collagen are natural, non-antigenic, porous bone mineral matrixes derived from bovine bone via removal of organic components. Physically and chemically comparable to human bone mineralized matrix. Available as cortical granules and blocks. Used by clinicians in oral and maxillofacial surgery to fill intra-osseous cavities, periodontal defects, extraction sockets, and peri-implant defects, or for sinus floor elevation. Acts as a scaffold for bone regeneration. The device is identical to previously cleared versions, with the only change being the addition of Australia as an alternative geographic source for bovine bone, supported by a risk assessment regarding BSE-risk.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the chemical and physical comparability to previously cleared predicate devices and a risk assessment regarding the alternative bovine bone source.

Technological Characteristics

Natural, non-antigenic, porous bovine bone mineral matrix. Available as cortical granules and blocks. Chemically and physically comparable to human bone mineralized matrix. No electronic components, software, or energy sources.

Indications for Use

Indicated for augmentation or reconstructive treatment of alveolar ridge; filling of periodontal defects; filling of defects after root resection, apicoectomy, and cystectomy; filling of extraction sockets for alveolar ridge preservation; elevation of maxillary sinus floor; filling of periodontal defects with GTR/GBR products; and filling of peri-implant defects with GBR products.

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

• BIO-OSS® (K871773, K952617, and K970321)
• BIO-OSS® Blocks (K920508, K952618, and K970569)
• BIO-OSS® Collagen (K974399)

Submission Summary (Full Text)

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JAN 1 5 2004

## 510(k) Summary

K033815

## BIO-OSS®

## BIO-OSS® Blocks

## BIO-OSS® Collagen

#### 1. SPONSOR

Geistlich Pharma Ag Bahnhofstrasse 40 CH-6110 Wolhuscn SWITZERLAND

Contact Person: Dr. Susana Wäsch, 011-41-41-49-25-630 Date Prepared: December 5, 2003

#### 2. DEVICE NAME

| Proprietary Name: | BIO-OSS®, BIO-OSS® Blocks, BIO-OSS® Collagen |
|----------------------|----------------------------------------------|
| Common/Usual Name: | Anorganic Bovine Bone Filling Material |
| Classification Name: | Bone Filling Material |

#### 3. PREDICATE DEVICES

BIO-OSS® (K871773, K952617, and K970321) BIO-OSS® Blocks (K920508, K952618, and K970569) BIO-OSS® Collagen (K974399)

#### 4. INTENDED USE

BIO-OSS®, BIO-OSS Blocks and BIO-OSS® Collagen are recommended for:

- . Filling of large oral and maxillofacial intra-osseous cavities
#### ડ. DEVICE DESCRIPTION

BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are natural non-antigenic, porous bone mineral matrixes. They arc produced by removal of all organic components from bovinc bone. Due to its natural structure, BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are physically and chemically comparable to the mineralized matrix of human bone. It is available as cortical granules and blocks.

#### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen are substantially equivalent to Geistlich's existing products, BIO-OSS® Anorganic Bovine Bone (K871773, K952617, and K970321), BIO-OSS® Blocks (K920508, K952618, and K970569), and BIO-OSS®

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Collagen (K974399). The only difference between the new products and the products previously cleared is that an alternative geographic source for the bovine bone is proposed to be added - Australia. The current source of bone is the United States. The European Union, in its Report on the Assessment of the Geographical BSE-risk of Australia, found Australia to have a level I Geographical BSE-risk ("GBR") - which means that it is highly unlikely that there is the presence of one or more cattle clinically or pre-clinically infected with the BSE agent in Australia. The United States has a level II GBR. It should be noted that Australia is not on the U.S. Department of Agriculture's list of countries affected with BSE. See 9 C.F.R. § 94.18. The company has performed a Risk Assessment per FDA Guidance to address traceability and pedigree of the herds. Therefore, using an alternative source of bovine bone will not negatively impact the products' safety or effectiveness.

With regard to the safety and effectiveness of the anorganic bovine bone used in BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen Geistlich incorporates by reference all of the information on the use of BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen in the above referenced 510(k) submissions.

BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen, as proposed to be sourced are substantially equivalent to the existing BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen products, in substance, function and intended use.

Based on the forcgoing, Geistlich believes that the information and data herein submitted demonstrates not only that these versions of BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen arc substantially equivalent to existing BIO-OSS®, BIO-OSS® Blocks, and BIO-OSS® Collagen products but also that these products have been shown to be safe and effective for the labeled indications.

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Image /page/2/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 depiction of a human figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 5 2004

Geistlich-Pharma Ag C/O Mr. Peter S. Reichertz Sonnenschein Nath & Rosenthall LLP 1301 K Street NW Suite 600, East Tower Washington, D.C. 20005

Re: K033815

Trade/Device Name: BIO-OSS Granules, BIO-OSS Blocks and BIO-OSS Collagen Regulation Number: None Regulation Name: Nonc Regulatory Class: Unclassified Product Code: NPM Dated: December 8, 2003 Received: December 12, 2003

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 r mondinely of od, 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 Eederal 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 maj country 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,

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

Enclosure

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K033815

## Indications for Use

510(k) Number (if known): K033815

Device Name: BIO-OSS Granules, BIO-OSS Blocks and BIO-OSS Collagen

Indications for Use:

Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filing of defects after root resection, apicocctomy, and cystectomy Filing of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor

Filling of periodontal defects in conjunction with products intended for Guided Tissue Regencration (GTR) and Guided Bone Regencration (GBR).

Filing of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Over-The-Counter Use レ Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runge

Page 1 of

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vision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

25103438\V-1