FUJI I

K980695 · GC America, Inc. · EMA · Apr 13, 1998 · Dental

Device Facts

• Record ID: K980695
• Device Name: FUJI I
• Applicant: GC America, Inc.
• Product Code: EMA · Dental
• Decision Date: Apr 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fuji I is a self-cure glass ionomer material intended for the use as a luting cement for cementation of inlays, crowns, bridges and orthodontic bands.

Device Story

Fuji I is a self-cure glass ionomer dental cement. Used by dental professionals in clinical settings for the permanent cementation of prosthetic restorations including inlays, crowns, bridges, and orthodontic bands. The material functions as a luting agent to bond dental prosthetics to tooth structure. It is applied by the clinician during restorative or orthodontic procedures to secure the device in place, providing retention and sealing. Benefits include stable fixation of dental appliances.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-cure glass ionomer luting cement. Chemical composition typical of glass ionomer restorative materials. Formulated for manual mixing and application in dental procedures.

Indications for Use

Indicated for use as a luting cement for the cementation of inlays, crowns, bridges, and orthodontic bands in dental patients.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of curved lines and shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 1 3 1998

K980695 Re : Trade Name: Fuji I Requlatory Class: II Product Code: EMA February 19, 1998 Dated: Received: February 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 regulations 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) 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 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 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

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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K980695

## INDICATIONS FOR USE

Device Name: FUJI I

Indications For Use: Fuji I is a self-cure glass ionomer material intended for the use as a luting cement for cementation of inlays, crowns, bridges and orthodontic bands.

Susan Rumsey

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 2980095