GC FUJI ORTHO LC

K981461 · GC America, Inc. · DYH · Jun 25, 1998 · Dental

Device Facts

• Record ID: K981461
• Device Name: GC FUJI ORTHO LC
• Applicant: GC America, Inc.
• Product Code: DYH · Dental
• Decision Date: Jun 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

GC Fuji Ortho LC is a glass ionomer dental cement designed for use as an orthodontic adhesive for brackets, bands and bonded appliances.

Device Story

GC Fuji Ortho LC is a glass ionomer dental cement used by dental professionals for bonding orthodontic brackets, bands, and appliances to tooth surfaces. The device functions as an adhesive material to secure orthodontic hardware. It is applied in a clinical setting by a dentist or orthodontist. The cement provides a chemical bond to tooth structure, facilitating the stabilization of orthodontic appliances during treatment. Its use assists in the correction of malocclusions and other dental alignment issues by ensuring the secure attachment of orthodontic components.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Glass ionomer dental cement; chemical bonding agent; supplied as a restorative material for orthodontic applications.

Indications for Use

Indicated for use as an orthodontic adhesive for bonding brackets, bands, and appliances in dental patients.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1998

Ms. Terry L. Joritz Director-Regulatory Affairs & Quality Control Official Correspondent GC AMERICA INCORPORATED 3737 West 127th Street Chicago, Illinois 60658

Re: K981461 GC Fuji Ortho LC Trade Name: Requlatory Class: II Product Code: DYH Dated: April 22, 1998
Received: April 23, 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 The general controls provisions of the Act 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 (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. ನ್ನ 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 requlatory 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 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 markets 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.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot AA. 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 ORTHO LC Modified

Indications For Use: GC Fuji Ortho LC is a glass ionomer dental cement designed for use as an orthodontic adhesive for brackets, bands and bonded appliances.

Herald Sheppard

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

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