(100 days)
SDF Pro is intended to be used by dental professionals to treat tooth hypersensitivity. For use in adults over the age of 21.
Not Found
This FDA 510(k) clearance letter for the SDF Pro device does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.
The letter's primary purpose is to confirm substantial equivalence of the SDF Pro to a legally marketed predicate device, allowing it to be marketed. It details:
- Device Name: SDF Pro
- Applicant: Belport Company, Inc., Gingi-Pak
- Regulation Number and Name: 21 CFR 872.3260, Cavity Varnish
- Regulatory Class: Class II
- Product Code: PHR
- Indications for Use: Intended to be used by dental professionals to treat tooth hypersensitivity in adults over the age of 21.
Therefore, it is impossible to provide the requested information based on the provided text.
The document is a clearance letter, not a summary of the technical or clinical performance data submitted for the clearance. Clinical study data, including acceptance criteria, performance metrics, sample sizes, ground truth establishment, and expert qualifications, would typically be found in the original 510(k) submission document itself, which is not provided here.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.