BIO-OSS COLLAGEN

K974399 · Geistlich-Pharma · LYC · Sep 16, 1998 · Dental

Device Facts

• Record ID: K974399
• Device Name: BIO-OSS COLLAGEN
• Applicant: Geistlich-Pharma
• Product Code: LYC · Dental
• Decision Date: Sep 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicoectomy, and cystectomy Filling 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 Regeneration (GTR) and Guided Bone Regeneration (GBR). Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Device Story

Bio-Oss Collagen is a bone graft substitute material used in dental and oral surgery. It serves as a scaffold for bone regeneration in various clinical scenarios, including ridge augmentation, periodontal defect filling, and sinus floor elevation. The device is applied by a dental surgeon or clinician directly into the surgical site. It acts as an osteoconductive matrix, supporting the patient's natural bone healing process. By filling defects and extraction sockets, it aids in preserving alveolar ridge volume and preparing sites for dental implants. The collagen component provides handling characteristics that facilitate placement in the defect site. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) notification review.

Technological Characteristics

Bone graft substitute material containing collagen. Osteoconductive matrix. Formulated for dental/oral surgical applications. Prescription use only.

Indications for Use

Indicated for patients requiring alveolar ridge augmentation/reconstruction, periodontal defect filling, filling of defects post-root resection/apicoectomy/cystectomy, extraction socket preservation, maxillary sinus floor elevation, and filling of peri-implant defects. Used in conjunction with GTR/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.

Submission Summary (Full Text)

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

SEP 16 1998

Geistlich-Pharma
C/O Mr. Peter S. Reichertz
Attorneys at Law
Arent Fox Kintner and Kahn, PLLC
1050 Connecticut Avenue, NW
Washington, DC 20036-5339

Re: K974399
Trade Name: Bio-Oss Collagen
Regulatory Class: Unclassified
Product Code: LYC
Dated: August 11, 1998
Received: August 18, 1998

Dear Mr. Reichertz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Reichertz

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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$10(k) Number (if known): K974399

Device Name: BIO-OSS Collagen

## Indications For Use:

- Augmentation or reconstructive treatment of alveolar ridge
- Filling of periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling 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 Regeneration (GTR) and Guided Bone Regeneration (GBR).

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runn

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K974399

OR

Over-The-Counter Use

Prescription Use ☑ (Per 21 CFR 801.109)

(Optional Format 1-2-96)