(77 days)
Bosworth Seal is a light-activated dental sealant for sealing pits and fissures of anterior and posterior teeth. The Bosworth Seal is a surface glaze and is used for denture and orthodontic retention systems.
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This document is a 510(k) clearance letter from the FDA for a dental pit and fissure sealant called "Bosworth Seal." It does not contain information about acceptance criteria, device performance, or any studies. The letter is a regulatory approval, not a scientific report detailing clinical trials or performance evaluations.
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§ 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.