(23 days)
DELTON® Illuminating Pit and Fissure Sealant is indicated for preventive sealing of pits and DELT ON® Inummanding in and secondary dentition in combination with the acid-etch technique.
The DELTON® Illuminating Pit & Fissure Sealant is a pit and fissure sealant containing releasable fluoride. The sealant contains a dye that is not visible in ordinary light but fluoresces a blue-white upon exposure to UVA light. Fluorescence provides contrast with natural dentition for margin inspection.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria for the DELTON® Illuminating Pit & Fissure Sealant. The document is a 510(k) summary and an FDA clearance letter, which describes the device, its intended use, and its substantial equivalence to a predicate device but does not contain detailed study results or acceptance criteria tables. Therefore, I cannot generate the requested table and information.
§ 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.