UNIGRAFT

K993784 · Unicare Biomedical · LYC · Jan 27, 2000 · Dental

Device Facts

• Record ID: K993784
• Device Name: UNIGRAFT
• Applicant: Unicare Biomedical
• Product Code: LYC · Dental
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge

Device Story

Unigraft is a synthetic bioactive glass (45S5 Bioglass) bone graft material; supplied as irregular granules (200-420 microns). Used by clinicians in dental/oral surgery for repair of periodontal infrabony defects, extraction sites, and alveolar ridge augmentation. Upon implantation, granules undergo time-dependent surface modification, forming a calcium phosphate layer structurally equivalent to bone hydroxyapatite. This layer acts as an osteo-conductive scaffold, promoting new osseous tissue generation. Device provides a synthetic alternative to autograft or allograft materials, facilitating bone filling and augmentation in oral defects.

Clinical Evidence

Bench testing only; comparative evaluation against predicate devices demonstrated substantial equivalence.

Technological Characteristics

Synthetic bioactive glass (45S5 Bioglass) granules; size 200-420 microns. Osteo-conductive scaffold mechanism via surface reaction forming calcium phosphate/hydroxyapatite layer. Non-resorbable/bioactive ceramic composition.

Indications for Use

Indicated for patients requiring repair of periodontal infrabony defects, extraction sites, or alveolar ridge augmentation.

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

• PerioGlas®
• BioGran®
• OsteoGraf

Submission Summary (Full Text)

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K993784

## 510(k) summary (As Required by Section 807.92 (c))

#### 1. Submitter

| Name: | Unicare Biomedical, Inc. |
|----------|------------------------------------------------|
| Address: | 25951 La Cuesta Avenue, Laguna Hills, CA 92653 |
| Contact: | Stan Yang, 949-362-1772 |
| Date: | November 5, 1999 |

#### 2. Device Name

| Trade Name: | Unigraft |
|------------------------|------------------------------------------------------|
| Common Name: | Synthetic bone graft material |
| Classification Name: | Endosseous implant for bone filling and augmentation |
| Device Classification: | Class III |

#### 3. Predicate Devices

PerioGlas®, BioGran® and others

#### 4. Device Description

Unigraft is a synthetic bioactive glass material for use in the repair of oral defects, including periodontal defects, extraction sites and augmentation of the alveolar ridge. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.

The bioactive glass (45S5 Bioglass) used in Unigraft is one of the most extensively studied bioactive glass compositions, which has been shown to bond to bone as well as soft tissue. The same material is used in legally marketed devices, including BioGran® and PerioGlas®. When implanted in the living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone minerals. The biological apatite layer of the granules provides an osteo-conductive scaffold for the generation of new osseous tissue.

### 5. Comparison with Predicate Devices

The Unigraft 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 PerioGlas®. BioGran® and OsteoGraf. These products are made of bioactive ceramic materials with similar performance.

#### 6. Device Testing

The Unigraft device was evaluated comparatively against a predicate device using a variety of test methods. The results of these tests demonstrate that the Unigraft device is substantially equivalent to a predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 2 7 2000

Stan Yang, Ph.D. Unicare Biomedical, Incorporated 25951 La Cuesta Avenue Laquna Hills, CA 92653

Re : K993784 Trade Name: Unigraft Requlatory Class: Unclassified Product Code: LYC Dated: November 5, 1999 Received: November 8, 1999

Dear Dr. Yang:

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labelinq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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

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Paqe 2 - Dr. Yang

obligation you might have under sections 531 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 requlation (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" (21 CFR 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/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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510(K) NUMBER: K99-3784 DEVICE NAME: UNIGRAFT INDICATIONS FOR USE:

For the repair of periodontal infrabony defects, extraction site 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 Runner

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
610(k) Number 2993784