(45 days)
Quadrant Anterior Shine is a light curing dental composite filling material used in the adhesive restorative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue. Quadrant Anterior Shine is especially designed for the restoration of anterior teeth: a composite for aesthetic and cosmetic dentistry.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental filling material called "Quadrant Anterior Shine." This document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the letter does not contain any information about:
- Acceptance criteria or reported device performance metrics.
- Details of any study that proves the device meets specific acceptance criteria.
- Sample sizes (test or training sets).
- Data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance notification.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1998
Mr. Bernard van Duijn Manging Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem (Holland)
K983549 Re : Trade Name: Quadrant Anterior Shine Regulatory Class: II Product Code: EBF October 6, 1998 Dated: October 9, 1998 Received:
Dear Mr. van Duijn:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Van Duijn
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 requlation (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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
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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510(k) NUMBER (IF KNOWN):
DEVICE NAME: Quadrant Anterior Shine
INDICATIONS FOR USE:
Quadrant Anterior Shine is a light curing dental composite filling material used in the adhesive restorative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue.
Quadrant Anterior Shine is especially designed for the restoration of anterior teeth: a composite for aesthetic and cosmetic dentistry.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
W200
C Prescription Use (Per 21 CFR 801.109)
Over-The-Counter-Use (Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number
§ 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.