GRADIA GUM

K033808 · GC America, Inc. · EBF · Feb 2, 2004 · Dental

Device Facts

• Record ID: K033808
• Device Name: GRADIA GUM
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Feb 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

GRADIA GUM is a light-cured composite resin specifically used for the reproduction of the gum on crown and bridge prostheses.

Device Story

GRADIA GUM is a light-cured composite resin used by dental professionals in a laboratory or clinical setting to fabricate or repair the gingival (gum) portion of crown and bridge prostheses. The material is applied to the prosthetic framework and cured using a light source to achieve the desired physical properties and aesthetic appearance of natural gum tissue. It serves as a restorative material to improve the cosmetic outcome of dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured composite resin; classified as tooth shade resin material under 21 CFR 872.3690; Class II device.

Indications for Use

Indicated for the reproduction of gingival tissue on crown and bridge prostheses in dental patients.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2004

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

Re: K033808

Trade/Device Name: GRADIA GUM Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EBI Dated: December 05, 2003 Received: December 18, 2003

Dear Ms. Joritz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becates wined 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 Interstate conninered pror to that have been reclassified in accordance with the provisions of Amendinents, or to de roos that not is Act (Act) that do not require approval of a premarket the rederal I vod, Drug, and Commay, therefore, market the device, subject to the general approval application (1 the Act. The general controls provisions of the Act include confors provisions of the Fist - 110 Justing 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 If your device is oldsbirou (oos as additional controls. Existing major regulations affecting (1 Mrs), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or round ther announcements concerning your device in the Federal Register.

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Page 2 -- Ms. Terry L. Joritz

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements mean that FDA nas made a determinations administered by other Federal agencies. of the Act of ally I cucial statutes and regarents, including, but not limited to: registration You must comply with an the Fee s requirements (21 CFR Part 801); good manufacturing practice and listing (21 CF R F art 807), labeling 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) This letter will anow you to begil mationing of substantial equivalence of your device to a premits in the results in the PDF mixells 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 specific advice for your do research of the Security of county of a contributions on please contact the Office of Complians and access contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to [phone]. "Also, productions 17.97) you may obtain. Other general information on premaired nothbation (2) the Act may be obtained from the Division of Small your responsional 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,

Ches

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): _ K033808

Device Name: GRADIA GUM

Indications for Use:

GRADIA GUM is a light-cured composite resin specifically used for the reproduction of the gum on crown and bridge prostheses.

Prescription Use
(21 CFR Part 801 Subpart D)
✓

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

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