FUJI II

K980682 · GC America, Inc. · EMA · Apr 3, 1998 · Dental

Device Facts

• Record ID: K980682
• Device Name: FUJI II
• Applicant: GC America, Inc.
• Product Code: EMA · Dental
• Decision Date: Apr 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fuji II is a self-cure glass ionomer material intended for the use as a dental restorative for the following typical applications: - Restoration of primary teeth. - Core build-ups. - Class III, V and limited Class I cavities.

Device Story

Fuji II is a self-cure glass ionomer dental restorative material. Used by dental professionals in clinical settings for filling cavities and core build-ups. Material is mixed and applied to the tooth structure to restore form and function. Benefits include chemical adhesion to tooth structure and fluoride release. No electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Self-cure glass ionomer restorative material. Chemical setting mechanism. No energy source, software, or connectivity.

Indications for Use

Indicated for dental restoration in patients requiring treatment for primary teeth, core build-ups, and Class III, V, or limited Class I cavities.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3

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

Re: K980682 Trade Name: Fuji II Regulatory Class: II Product Code: EMA Dated: February 19, 1998 February 23, 1998 Received:

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 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. ਚ 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 requlation (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

Tim Wlodkowski

Time 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: Fuji II

Indications For Use: Fuji II is a self-cure glass ionomer material intended for the use as a dental restorative for the following typical applications:

- · Restoration of primary teeth.
- Core build-ups. .
- Class III, V and limited Class I cavities. .

Susan Puno

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