GRADIA DIRECT by GC AMERICA, INC.

The provided text is a 510(k) summary from the FDA for a dental restorative material named "Gradia Direct." This document is a clearance letter, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, the document does not contain any information regarding:

Acceptance criteria and reported device performance (in a quantifiable, study-driven manner)
Sample sizes used for test sets or their data provenance
Number of experts or their qualifications for establishing ground truth
Adjudication methods
Multi-reader multi-case (MRMC) comparative effectiveness studies
Standalone algorithm performance studies
Type of ground truth used (expert consensus, pathology, outcomes data) for performance evaluation
Sample size for training sets
How ground truth for training sets was established

This document is solely an FDA clearance letter indicating that the device can be legally marketed based on its substantial equivalence to pre-existing devices, rather than comprehensive performance data from a specific study.

Summary

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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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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.
1. Direct restorative for wedge-shaped defects and root surface cavities.
1. 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)

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

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
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.(b)
Classification. Class II.