GC FUJI BOND LC

K981514 · GC America, Inc. · KLE · Jun 16, 1998 · Dental

Device Facts

• Record ID: K981514
• Device Name: GC FUJI BOND LC
• Applicant: GC America, Inc.
• Product Code: KLE · Dental
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GC Fuji BOND LC modified is a dentin/enamel bonding material used to restore all cavities Class I, II, III, IV and V in combination with a light cured composite resin.

Device Story

GC Fuji BOND LC is a dental bonding material; used by dentists in clinical settings to facilitate adhesion between tooth structure (dentin/enamel) and light-cured composite resins. Applied during cavity restoration procedures (Classes I-V); functions as an interface to improve retention and marginal integrity of composite fillings. Benefits patient by providing a secure bond for restorative materials, reducing risk of microleakage and restoration failure.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench-level assessment of intended use and material function.

Technological Characteristics

Light-cured dentin/enamel bonding material. Formulated for use with light-cured composite resins. Class II medical device.

Indications for Use

Indicated for use as a dentin/enamel bonding agent for all cavity classes (I, II, III, IV, and V) when used in conjunction with light-cured composite resin restorative materials.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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Public Health Service

Jun 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry L. Joritz ·Director-Regulatory Affairs & Quality Control GC AMERICA INCORPORATED 3737 West 127th Street Alsip, Illinois 60803

Re : K981514 GC Fuji BOND LC Trade Name: Requlatory Class: II Product Code: KLE Dated: April 24, 1998 Received: April 28, 1998

Dear Ms. Joritz:

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Joritz

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 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.fdp.gov/cdrh/dsmamain.html" .

Sincerely yours

Timothy A. Ulatowski

thy A 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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## INDICATIONS FOR USE

## Device Name: GC FUJI BOND LC Modified

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Indications For Use: GC Fuji BOND LC modified is a dentin/enamel bonding material used to restore all cavities Class I, II, III, IV and V in combination with a light cured composite resin.

Susan Russo

(Division Sign-Off) Division of Donal, Infection Control, and General Hospital Devices 1987511 510(k) Number _