21 CFR § 872.3765
Pit and fissure sealant and conditioner
June 25, 2020
(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.
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