GC FUJI ORTHO BAND PASTE PAK

K020578 · GC America, Inc. · DYH · Apr 26, 2002 · Dental

Device Facts

• Record ID: K020578
• Device Name: GC FUJI ORTHO BAND PASTE PAK
• Applicant: GC America, Inc.
• Product Code: DYH · Dental
• Decision Date: Apr 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GC Fuji ORTHO BAND PASTE PAK is intended to be used for cementation of orthodontic bands. It is also used for the cementation of appliances retained with stainless steel crowns. I.e. Herbst or expansion appliances.

Device Story

GC Fuji ORTHO BAND PASTE PAK is a resin-modified glass ionomer cement used for orthodontic band and appliance cementation. The device is supplied in a paste-paste delivery system. It is used by dental professionals in a clinical setting. The cement provides adhesion to tooth structure and stainless steel, facilitating the secure attachment of orthodontic bands and appliances like Herbst or expansion devices. The product is applied by the clinician to the band or appliance, which is then seated on the tooth. The material sets to provide a durable bond, aiding in the stability of orthodontic treatment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Resin-modified glass ionomer cement. Paste-paste delivery system. Designed for adhesion to tooth structure and stainless steel. Class II device (Product Code: DYH).

Indications for Use

Indicated for cementation of orthodontic bands and appliances retained with stainless steel crowns (e.g., Herbst or expansion appliances) in patients requiring orthodontic treatment.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 6 2002

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

Re: K020578

Trade/Device Name: GC Fuji ORTHO BAND PASTE PAK Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: February 19, 2002 Received: February 21, 2002

Dear Ms. 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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Page 2 - Ms. Terry L. Joritz

You must comply with all the Act's requirements, including, but not limited to: registration Tourinust comply with and Hood Log (21 CFR Part 801); good manufacturing practice allo listing (21 CF RT art 807), labeling (21 CFR Part 820); and if requirents as set form in are quality six 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 I ins leter will anow you to cognization of substantial equivalence of your device to 310(k) promises noticate 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 If you desire up only 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the aller databliance at [phone]. Additionally, for questions on the promotion and Office of Comphilance wee, 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 notheation (21 OF ICP art 0011).
the Act may be obtained from the Division of Small Manufacturers, International and the receiner Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

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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510(k) Number (if known):

GC Fuii ORTHO BAND PASTE PAK Device Name:_

Indications For Use:

GC Fuji ORTHO BAND PASTE PAK is intended to be used for cementation of GCT the ONND PAOTE : It is also used for the cementation of appliances retained with stainless steel crowns. I.e. Herbst or expansion appliances.

K020574

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 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 Devices, 510(k) Number_100 (1)