(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.
§ 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.