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K Number
K042348
Device Name
GRADIA DIRECT LOFLO
Manufacturer
GC AMERICA, INC.
Date Cleared
2004-11-18

(80 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
K091388
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This product is a light-cured fluoride releasing microfilled hybrid composite restorative resin. Recommended Indications: 1. Restoration of Class I, II, III, IV, V cavities (particularly for small Class I cavities/ shallow Class V cavities/ other small cavities). 2. Restoration of root surface caries. 3. Restorations in deciduous teeth. 4. Filling tunnel shaped cavities. 5. Sealing hypersensitive areas. 6. Liner/base/filling in cavity undercuts. 7. Sealant. 8. Fixation of mobile teeth. 9. Additions to composite restorations.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental restorative material, not a study report detailing acceptance criteria and performance data for a device involving AI or complex statistical analysis.

Therefore, the requested information elements (1 through 9) related to a study proving device meeting acceptance criteria, especially those pertinent to AI/software performance, are not present in this document.

Specifically, there is no information regarding:

  1. A table of acceptance criteria and the reported device performance: This letter indicates substantial equivalence to a predicate device, not a performance study against specific acceptance criteria.
  2. Sample size used for the test set and the data provenance: No test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a dental material, not an AI-assisted diagnostic device.
  6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

This document serves as an FDA clearance for a dental material (Gradia® Direct LoFlo) based on its substantial equivalence to previously marketed predicate devices, not on a new clinical performance study with detailed acceptance criteria and statistical analysis as would be relevant for devices with diagnostic or AI components.

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that appears to be an eagle.

NOV 1 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042348

Trade/Device Names: Gradia® Direct LoFlo Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EMA Dated: August 27, 2004 Received: September 07, 2004

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 grneral controls provisions of the Act include requirements for annual registration, listing of devenes, 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 public further 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 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 (240) 276-0115. 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 yours.

Curt

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

Enclosure

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Indications for Use

510(k) Number (if known): K042348

Device Name:

Indications for Use:

GRADIA DIRECT LoFlo

This product is a light-cured fluoride releasing microfilled hybrid composite restorative resin.

Recommended Indications:

    1. Restoration of Class I, II, III, IV, V cavities (particularly for small Class I cavities/ shallow Class V cavities/ other small cavities).
    1. Restoration of root surface caries.
    1. Restorations in deciduous teeth.
    1. Filling tunnel shaped cavities.
    1. Sealing hypersensitive areas.
    1. Liner/base/filling in cavity undercuts.
    1. Sealant.
    1. Fixation of mobile teeth.
    1. Additions to composite restorations.

Prescription Use
(21 CFR Part 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kée Waler for MIR

UNISION of Anesthesion V. General Hosnital

510(k) Number: K042348

§ 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.