FUJI VII CAPSULE

K013198 · GC America, Inc. · EMA · Oct 29, 2001 · Dental

Device Facts

• Record ID: K013198
• Device Name: FUJI VII CAPSULE
• Applicant: GC America, Inc.
• Product Code: EMA · Dental
• Decision Date: Oct 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GC Fuji VII is a capsulated restorative glass ionomer cement intended. for : - Treatment of early non-cavitated Icsions; such as tooth brush . abrasion and Root surface sensitivity. - Pit and Fissure Sealant . - · Intermediate restorative material - · Temporary filling of endodontic access

Device Story

GC Fuji VII is a glass ionomer restorative cement provided in a capsule delivery system. Used by dental professionals in a clinical setting for restorative and preventive dental procedures. The material is applied to the tooth surface or cavity preparation to provide sealing, sensitivity relief, or temporary structural support. It functions as a chemical-setting restorative material. Benefits include protection against early lesions, management of root sensitivity, and provision of a temporary barrier for endodontic access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Glass ionomer restorative cement; supplied in a capsule delivery system; chemical-setting material; Class II device per 21 CFR 872.3275.

Indications for Use

Indicated for patients requiring treatment of early non-cavitated lesions (e.g., toothbrush abrasion, root surface sensitivity), pit and fissure sealing, intermediate restoration, or temporary filling of endodontic access.

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 is a black and white circular logo. The logo features a stylized abstract symbol in the center, resembling a bird in flight or a series of flowing lines. Encircling the symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the perimeter of the circle, with the symbol positioned in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2001

Mr. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America. Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K013198

Trade/Device Name: Fuji VII Capsule Regulation Number: 872.3275 Regulation Name: Glass Ionomer Restorative Cement Regulatory Class: II Product Code: EMA Dated: September 21, 2001 Received: September 25, 2001

## Dear Mr. Joritz:

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 such 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.

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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

W. Whitworth

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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ATACH MENT A ਜ of

510(k) Number (if known): __ K013198

Fuji VII Capsule Device Name:

Indications For Use:

GC Fuji VII is a capsulated restorative glass ionomer cement intended. for :

- Treatment of early non-cavitated Icsions; such as tooth brush . abrasion and Root surface sensitivity.
- Pit and Fissure Sealant .
- · Intermediate restorative material
- · Temporary filling of endodontic access

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Conizurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96).

Susan Rumm

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