(49 days)
For use as a tooth shade resin material in dental procedures
The product is a tooth shade resin material for use in dental restorations. It may be used with Tokuyama's Mac Bond II or other brands of similar bonding agents. It is not intended for DTC use. It contains materials that are common in dental use and pose no health hazard when used according to directions.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document appears to be a 510(k) summary and an FDA clearance letter for a dental resin material, focusing on its substantial equivalence to a predicate device rather than performance metrics and validation studies.
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.
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K9800S1
EXHIBIT D
FEB 2 4 1998
510(k) Summary
Daniel J. Manelli Submitted by: Farkas & Manelli, P.L.L.C. 1233 20th Street, NW (Suite 700) Washington, DC 20036
On behalf of Tokuyama America, Inc. 510(k) Submission: Tokuso Mac Bond II December 30, 1997
The product is a tooth shade resin material for use in dental restorations. It may be used with Tokuyama's Mac Bond II or other brands of similar bonding agents. It is not intended for DTC use. It contains materials that are common in dental use and pose no health hazard when used according to directions.
The Use ා i the product is contra-indicated for patients who are hypersensitive to methacrylate monomers. It should not be allowed to come into contact with skin or eyes. Should contact with the skin occur, the affected area should be washed thoroughly with soap and water. Should the product come into contact with the eyes, it should be immediately rinsed out thoroughly with water and a physician should be contacted at once.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
FEB 2 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel J. Manelli Attorney Tokuyama America, Incorporated C/O Farkas & Manelli, P.L.L.C. 1233 20th Street N.W. #700 Washington, DC 20036
Re : K980051 Palfique Estelite Paste Trade Name: Requlatory Class: II EBF Product Code: Dated: December 30, 1997 Received: January 6, 1998
Dear Mr. Manelli: ....
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 requlations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Manelli
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 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) 594-4618. 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,
Patricia Cusenitfor
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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Page 1 of 1
510(k) Number (if known):
Palfique Estelite Paste Device Name:
Indications For Use:
For use as a tooth shade resin material in dental procedures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runge
(Division Sign Off)
Division of Dental infection Control,
and General Hospital Devices
510(k) Number: I2980051
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.