(76 days)
Prime-Dent® Visible Light Cure Pit & Fissure Sealant (opaque and clear) is a BisGMA based visible light cured resin for the sealing of deciduos teeth and the filling of fissures in primary tooth structure.
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This is an FDA Premarket Notification (510(k)) for a dental sealant. This type of document declares "substantial equivalence" to a predicate device, meaning it's similar enough that it doesn't require new clinical trials like a premarket approval (PMA) would. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them.
The FDA letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device..."
To answer the requested questions, one would need different documentation, such as a PMA submission or a clinical study report for a novel device.
§ 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.