(84 days)
BeautiSealant is resin material intended for sealing of pits and fissures, which is polymerized by visible light energy (external energy). 'Primer' modifies enamel surface with its adhesive monomer to bond 'Paste' to enamel.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA letter regarding a 510(k) premarket notification for a dental product called "BeautiSealant." It discusses regulatory compliance and substantial equivalence to predicate devices, but it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
§ 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.