GRADIA DIRECT

K023814 · GC America, Inc. · EBF · Jan 30, 2003 · Dental

Device Facts

• Record ID: K023814
• Device Name: GRADIA DIRECT
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Jan 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below: GRADIA DIRECT ANTERIOR: 1. Direct restorative for Class III, IV and V cavities. 2. Direct restorative for wedge-shaped defects and root surface cavities. 3. Direct restorative for veneers and diastema closure. GRADIA DIRECT POSTERIOR: 1. Direct restorations for Class I and II cavities.

Device Story

Gradia Direct is a visible light-cured micro-filled hybrid resin used by dentists for direct dental restorations. It is applied to tooth cavities or surfaces to restore structure and aesthetics. The material is cured using a dental light source. It serves as a restorative agent for anterior (Class III, IV, V, veneers, diastema closure) and posterior (Class I, II) applications. It benefits patients by providing a durable, aesthetic tooth-colored filling material.

Clinical Evidence

Bench testing only.

Technological Characteristics

Visible light-cured micro-filled hybrid resin. Class II device. Product code 76 EBF.

Indications for Use

Indicated for patients requiring direct dental restorations, including Class I, II, III, IV, and V cavities, wedge-shaped defects, root surface cavities, veneers, and diastema closure.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, representing health and well-being. The figure is enclosed within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2003

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

Re: K023814

Trade/Device Name: Gradia Direct Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: 76 EBF Dated: November 11, 2002 Received: November 15, 2002

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.

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Page 2 - Mr. Joritz

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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16 2 3 814 510(k) Number (if known):

Device Name:_ _Gradia_Direct___

Indications For Use:

GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below:

## GRADIA DIRECT ANTERIOR:

- 1. Direct restorative for Class III, IV and V cavities.
- 2. Direct restorative for wedge-shaped defects and root surface cavities.
- 3. Direct restorative for veneers and diastema closure.

GRADIA DIRECT POSTERIOR:

- 1. Direct restorations for Class I and II cavities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Formal 1 -: -96)

Kevin Muluy for MSR

(Division Sign-Off) (Division Sign-off)
Division of Anesthesiology, General Hospital, Division of Antol, Dental Devices

510(k) Number: K023814