(96 days)
Use UltraSeal XT plus for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental sealant product called "UltraSeal XT Plus." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Based on the content of the provided text, I cannot answer your request. The document discusses regulatory approval for a dental sealant and does not include the type of technical study details you are asking for.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2000
Dr. Dan Fisher President Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re : K993846 UltraSeal XT Plus Trade Name: Regulatory Class: II Product Code: EBC Dated: January 28, 2000 Received: January 31, 2000
Dear Dr. Fisher:
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 Regulations, 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Dr. Fisher
the Federal Register. Please note: this response to your the rederal notification submission does not affect any premarker noctricacion baskibility sections 531 through 542 of obligation you might have ahe around Product Radiation the Act for devices ander enderal laws or regulations.
This letter will allow you to begin marketing your device as Inis iceed will arrew your for market notification. The FDA described in your 510 k; premainos newslevice to a legally rinding or bubbeanceal oggresults in a classification for your marketed predicate device rosadesice 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 regulacion (ir devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact che promocron and livere at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Infoimation on your respon of Small Manufacturers Assistance obtained from che Divisa(800) 638-2041 or (301) 443-6597 or at at fes corr free namble (p://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: _________________________________________________________________________________________________________________________________________________________________ UltraSeal XT plus
Indications For Use:
Use UltraSeal XT plus for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Susan Runne
Over-The-Counter Use
(Optional Format 1-2-9«
(Division Sign-Off) Division of Dental, Infection Control, ond General Hospital Devices - U-510(k) Number _
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.