OSSIFORM

K020720 · Unicare Biomedical, Inc. · LYC · May 7, 2002 · Dental

Device Facts

• Record ID: K020720
• Device Name: OSSIFORM
• Applicant: Unicare Biomedical, Inc.
• Product Code: LYC · Dental
• Decision Date: May 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, sinus lifts, cystic defects, extraction sites, craniofacial augmentation and augmentation of the alveolar ridge.

Device Story

Ossiform is a synthetic bioactive glass bone graft material; supplied as granules in a sterile polyolefin vial. Used by dental and oral/maxillofacial surgeons to fill or augment intraosseous defects; facilitates bone repair/regeneration. Applied directly to the defect site during surgical procedures. Acts as a scaffold for bone growth; bioactive properties promote integration with host tissue. Benefits include structural support and defect resolution in oral/maxillofacial applications.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Synthetic bioactive glass granules; supplied sterile in polyolefin vials. Material functions as an endosseous implant for bone filling/augmentation. No electronic or software components.

Indications for Use

Indicated for patients requiring bone filling or augmentation in dental intraosseous and oral/maxillofacial defects, including periodontal defects, ridge augmentation, extraction sites, cranio-facial augmentation, sinus lifts, and cystic defects.

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

• Unigraft
• PerioGlas
• BioGran

Submission Summary (Full Text)

{0}------------------------------------------------

K020720

## 510(k) summary

(As Required by Section 807.92 (c))

- Unicare Biomedical, Inc. 1. Name: 25951 La Cuesta Avenue, Laguna Hills, CA 92653 Address: Stan Yang, 949-643-6707 Contact: February 28, 2002 Date:
- Ossiform 2. Trade Name: Synthetic bone graft material Common Name: Endosseous implant for bone filling and augmentation Classification Name: Unclassified Device Classification:
- 3. Device Description

Ossiform is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.

### 4. Predicate Devices

The Ossiform device is substantially equivalent to devices currently in US commercial distribution, which are classified as endosseous implant for bone filling and augmentation. Examples of such products include Unigraft®, PerioGlas® and BioGran®. These products are made of bioactive ceramic materials with similar performance.

### 5. Intended Use

Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, ridge augmentation, extraction sites, cranio-facial augmentation, sinus lifts and cystic defects

- 6. Device Testing
The performance of Ossiform was evaluated using a variety of test methods. The results of these tests demonstrate that Ossiform is substantially equivalent to a predicate device.

{1}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures, depicted as flowing, abstract shapes. The figures are stacked on top of each other, creating a sense of unity and support.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 7 2002

Mr. Stan Yang Vice President Unicare BioMedical, Incorporated 25951 La Cuesta Avenue Laguna Hills, California 92653

Re: K020720

Trade/Device Name: OSSIFORM Regulation Number: None Regulation Name: Endosseous Implant Regulatory Class: Unclassified Product Code: LYC Dated: March 1, 2002 Received: March 5, 2002

Dear Mr. Yang:

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.

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.

{2}------------------------------------------------

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

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

Enclosure

{3}------------------------------------------------

# K020720

510(K) NUMBER: DEVICE NAME: OSSIFORM INDICATIONS FOR USE:

Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, sinus lifts, cystic defects, extraction sites, craniofacial augmentation and augmentation of the alveolar ridge.

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)

Susan Gunner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________