(50 days)
Dental pit and fissure sealant .
Cosmedent PIT & FISSURE SEALANT is a light-cure, moderately filled, resin based dental sealant. The product will cure or harden upon application of visible light at a wavelength of approximately 465 nanometers at an energy of at least 350 milliwatts. PIT & FISSURE SEALANT is a relatively low viscosity polymerizable resin based on bis-GMA, urethane, or similar room temperature curing diacrylate monomers. The product is intended to be applied to the developmental grooves and fissures of teeth to prevent these areas from being damaged by carious organisms. PIT & FISSURE SEALANT is available either as a clear unfilled resin or as a filled resin. The filled resin is white and mimics occlusal tooth color.
This document is a 510(k) summary for a dental pit and fissure sealant. It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical AI/ML devices. Instead, it focuses on the device's description, intended use, and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence, not on specific performance criteria derived from a clinical or technical study as would be relevant for an AI/ML 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.