MODIFICATION TO UNIGRAFT

K092567 · Unicare Biomedical, Inc. · LYC · Nov 25, 2009 · Dental

Device Facts

• Record ID: K092567
• Device Name: MODIFICATION TO UNIGRAFT
• Applicant: Unicare Biomedical, Inc.
• Product Code: LYC · Dental
• Decision Date: Nov 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Unigraft® is indicated for the repair of dental intraosseous and oral/maxillofacial defects, including: augmentation of the alveolar ridge, filling of infrabony periodontal defects, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of the maxillary sinus floor, filling of defects after cystectomy, apicoectomy and root resection, filling of periodontal and peri-implant defects in conjunction with products intended for GTR and GBR procedures, and filling of maxillofacial osseous cavities

Device Story

Unigraft is a synthetic bioactive glass bone graft material. Supplied as sterile granules in polyolefin vials. Used by dental and oral/maxillofacial surgeons to fill and augment intraosseous defects. Material acts as a scaffold for bone repair and regeneration in clinical settings. Applied directly to the defect site to facilitate healing and structural support.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material performance similarities to predicate devices.

Technological Characteristics

Synthetic bioactive glass granules. Supplied sterile in polyolefin vials. Class II endosseous implant for bone filling and augmentation. Bioceramic material composition.

Indications for Use

Indicated for patients requiring repair of dental intraosseous and oral/maxillofacial defects, including alveolar ridge augmentation, periodontal defect filling, extraction socket preservation, maxillary sinus floor elevation, and filling of osseous cavities following cystectomy, apicoectomy, or root resection.

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® (K092567)
• PerioGlas®
• Osteograf®

Submission Summary (Full Text)

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

K092567

## Attachment 5 - 510K Summary

510(K) summary (As Required by Section 807.92 (c))

| Name: | Unicare Biomedical, Inc. |
|----------|--------------------------------------------------|
| Address: | 22971 Triton Way, Unit B, Laguna Hills, CA 92653 |
| Contact: | Stan Yang, 949-643-6707 |
| Date: | August 16, 2009 |

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

### Device Description

Unigraft 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.

#### Predicate Devices

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

#### Intended Use

Unigraft® is indicated for the repair of dental intraosseous and oral/maxillofacial defects, including: augmentation of the alveolar ridge, filling of infrabony periodontal defects, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of the maxillary sinus floor, filling of defects after cystectomy, apicoectomy and root resection, filling of periodontal and peri-implant defects in conjunction with products intended for GTR and GBR procedures, and filling of maxillofacial osseous cavities

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three curved lines representing the wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NDV 2 5 2009

Mr. Stan Yang Vice President Unicare Biomedical, Incorporated 22971 Triton Way, Unit B Laguna Hills, California 92653

Re: K092567

Trade/Device Name: Unigraft® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 18, 2009 Received: November 24, 2009

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 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.

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

# Page 2- Mr. Yang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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

K092567

Attachment 7 - Indications For Use Statement

510K Number: _________________________________________________________________________________________________________________________________________________________________

Device Name: Unigraft®

Indications for Use:

Unigraft® is indicated for the repair of dental intraosseous and oral/maxillofacial defects, including: augmentation of the alveolar ridge, filling of infrabony periodontal defects, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of the maxillary sinus floor, filling of defects after cystectomy, apicoectomy and root resection, filling of periodontal and peri-implant defects in conjunction with products intended for GTR and GBR procedures, and filling of maxillofacial osseous cavities

Concurrence of CDRH, Office of Device Evaluation (ODE)

or Over-The-Counter Use Prescription Use X (Optional Format 1-2-96) (Per 21 CFR 801.109)

Neila N. Nolen for Kevin Muhly
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K092567

page 15 of 15