UNIGRAFE

K982699 · Unicare Biomedical · LYC · Oct 20, 1998 · Dental

Device Facts

• Record ID: K982699
• Device Name: UNIGRAFE
• Applicant: Unicare Biomedical
• Product Code: LYC · Dental
• Decision Date: Oct 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Unigraft is indicated for use in infrabony defects caused by periodontal diseases.

Device Story

UniGraft is a synthetic bioactive glass material used for bone filling and augmentation in periodontal disease treatment. The device consists of irregular synthetic granules (200-420 microns). Upon implantation, the material undergoes surface modification, forming a calcium phosphate layer structurally equivalent to hydroxyapatite in bone mineral. This layer facilitates bonding to bone and soft tissue. The device is intended for clinical use by dental professionals to treat bony defects.

Clinical Evidence

Bench testing only. The device was evaluated using comparative laboratory methods including FT-IR (Fourier Transform Infrared Spectroscopy), XRD (X-Ray Diffraction), EDX (Energy Dispersive X-ray spectroscopy), and bioactivity response testing to characterize the material and confirm substantial equivalence to predicate devices.

Technological Characteristics

Synthetic bioactive glass granules; size 200-420 microns. Principle of operation involves time-dependent surface modification in vivo to form a calcium phosphate (hydroxyapatite-like) bonding interface. Material is a bioactive ceramic.

Indications for Use

Indicated for use in patients with infrabony defects caused by periodontal diseases.

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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K982699

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

# 1. Submitter

| Name: | Unicare Biomedical |
|----------|------------------------------------------------|
| Address: | 25951 La Cuesta Avenue, Laguna Hills, CA 92653 |
| Contact: | Stan Yang, 949-362-1772 |
| Date: | July 30, 1998 |

# 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 used for the treatment of bony defects caused by periodontal diseases. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.

The bioglass used in UniGraft is one of the most extensively studied bioactive glass compositions, and has been shown to bond to bone as well as soft tissue. 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 in bone mineral. This apatite layer provides the bonding interface with bone and certain types of soft 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

Testing of UniGraft was designed to characterize the finished device and to assure the biocompatibility of the device. The UniGraft device was evaluated comparatively against a predicate device using test methods, including FT-IR, XRD, EDX, bioactivity response and others. The results of these tests demonstrate that the UniGraft device is substantially equivalent to a predicate device.

Confidential

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 1998

Stan Yang, Ph.D. Vice President Unicare Biomedical 2595 La Cuesta Avenue 92653 Laguna Hills, California

K982699 Re : Uniqraft Trade Name: Requlatory Class: Unclassified Product Code: LYC Dated: July 30, 1998 Received: August 3, 1998

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any 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.

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Page 2 - Dr. Yang

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" (21 CFR 807.97). Other gener 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: K982699

Device Name: Unigraft

Indications For Use:

: ・

Unigraft is indicated for use in infrabony defects caused by periodontal diseases.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use -(Per 21 CFR801.109)

or

Over-The-Counter Use (Optional Format 1-2-96)

Donald Stupp
(Division Sign-Off)

(Division of Dental, Infection Control, and General Hospital, Infection 510(k) Number J