(23 days)
- treatment of hypersensitive dentine
- treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas etc.)
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "Admira Protect and Admira Protect Single Dose." It does not contain any information about acceptance criteria or a study proving device performance against such criteria.
The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It details:
- Device Name: Admira Protect and Admira Protect Single Dose
- Regulation Number and Name: 872.3765, Pit and Fissure Sealant and Conditioner
- Regulatory Class: II
- Product Code: EBC
- Date of Approval: July 21, 2006
- Indications for Use:
- Treatment of hypersensitive dentine
- Treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas, etc.)
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information would typically be found in the 510(k) submission summary or a separate clinical study report, not in the clearance letter itself.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2006
Dr. Michael Süs Manager for Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 Cuxhaven. Germany 27472
Re: K061823
Trade/Device Name: Admira Protect and Admira Protect Single Dose Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: June 26, 2006 Received: June 28. 2006
Dear Dr. Süs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 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 HI (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. În addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 Dr. Michael Süs
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including. but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-fice number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.
Sincerely vours.
Chiu Lin. Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K061823
Device Name: Admira Protect and Admira Protect Single Dose J
Indications for Use:
- treatment of hypersensitive dentine •
- treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas etc.)
Prescription Use __X
OR
Over-The-Counter Use _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Koledshetzous for Dr. Aaron Kanner
(sign-off)
esthesiblogy. General Hospital
Number KC61823
§ 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.