(24 days)
Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva.
Prevora Stage 2 is to be applied by a licensed dental professional in a dental office, to the full dentition of the patient immediately after Prevora Stage 1 is applied and dried on these same teeth of the patient.
Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva.
The provided text is an FDA 510(k) clearance letter for a dental device called "Prevora Stage 2". This document does not contain any information about acceptance criteria, device performance, or any studies conducted.
The letter primarily indicates that the device has been reviewed and found substantially equivalent to a legally marketed predicate device (Chlorzoin Stage 2, #K944934). It outlines regulatory compliance requirements for marketing the device.
Therefore, I cannot provide the requested information, including acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as none of this data is present in the provided text.
§ 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.