(49 days)
GC Fuji BOND LC modified is a dentin/enamel bonding material used to restore all cavities Class I, II, III, IV and V in combination with a light cured composite resin.
Not Found
I am sorry, but based on the provided document, I cannot extract any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a product named "GC Fuji BOND LC Modified." This letter states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework for its marketing.
The only relevant sections in terms of product claims are the "Indications for Use" statement, which specifies that "GC Fuji BOND LC modified is a dentin/enamel bonding material used to restore all cavities Class I, II, III, IV and V in combination with a light cured composite resin." However, this section does not detail acceptance criteria or present any study results.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Information about MRMC comparative effectiveness studies or effect sizes.
- Information about standalone performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
Public Health Service
Jun 1 6 1998
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 : K981514 GC Fuji BOND LC Trade Name: Requlatory Class: II Product Code: KLE Dated: April 24, 1998 Received: April 28, 1998
Dear Ms. Joritz:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Joritz
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact. the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdp.gov/cdrh/dsmamain.html" .
Sincerely yours
Timothy A. Ulatowski
thy A 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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INDICATIONS FOR USE
Device Name: GC FUJI BOND LC Modified
Indications For Use: GC Fuji BOND LC modified is a dentin/enamel bonding material used to restore all cavities Class I, II, III, IV and V in combination with a light cured composite resin.
Susan Russo
(Division Sign-Off) Division of Donal, Infection Control, and General Hospital Devices 1987511 510(k) Number _
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.