(33 days)
Quadrant Postericr Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minir al invasive technique for maximal preservation of sound dental tissue. Quadrant Posterior Dense is specifically designed for the restoration of posterior teeth, using the same application instruments and techniques as for dental amalgam.
light curing dental composite filling material
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental filling material. It does not contain any information about acceptance criteria, device performance, a study, or any of the other details requested in your prompt regarding artificial intelligence or medical imaging devices. Therefore, I cannot fulfill your request based on the given input.
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DEC 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bernard van Duijn Manging Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem (Holland)
Re : K984044 Trade Name: Quadrant Posterior Dense Regulatory Class: II Product Code: EBF Dated: November 11, 1998 November 13, 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, 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. A 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 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 leqally 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): K984044
DEVICE NAME: Quadrant Posterior Dense
INDICATIONS FOR USE:
Quadrant Postericr Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minir al invasive technique for maximal preservation of sound tooth tissue.
Quadrant Posterior Dense is specifically designed for the restoration of posterior teeth, using the same application instruments and techniques as for dental amalgam.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 8(1.109)
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Rumm
OR
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 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.