(171 days)
Pulpdent's Activa Pit and Fissure Sealant with MCP is intended to seal pit and fissure depressions/faults in the enamel, in the biting surfaces of teeth. For dental professional use only.
Activa Pit and Fissure Sealant is a light cured, flowable dental sealant material, available in a single barrel syringe. This sealant is designed with MCP (Modified Calcium Phosphate); it releases calcium, phosphate, and fluoride ions into the oral environment. It contains no Bisphenol A, no BisGMA, and no BPA derivatives.
This document is a 510(k) premarket notification for a dental pit and fissure sealant. It does not describe an AI/ML-driven medical device, and therefore the requested information regarding acceptance criteria and study data for an AI/ML device is not present in the provided text.
The document discusses substantial equivalence to a predicate device based on material composition, intended use, and physical properties, not on performance metrics of an AI algorithm.
Therefore, I cannot extract the information required by your prompt from the provided text.
§ 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.