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Pulpdent Seal-Rite™ UDMA is a radiopaque, fluoride-releasing, visible light cure dental material for sealing the pits and fissures of teeth.

Pulpdent Seal-Rite™ UDMA is a radiopaque, fluoride-releasing, visible light cure dental material for sealing the pits and fissures of teeth. It contains no Bisphenol A. It is supplied as a medium consistency paste, which flows readily from cusp to cusp and is easily distinguishable from enamel. Pulpdent Seal-Rite™ UDMA cures completely after light curing for 20 seconds. Various formulations (with and without color, with and without fluoride) will be offered to allow for the clinician's discretion and preference in different situations. Pulpdent Seal-Rite" UDMA complies with ANSI/ADA Specification No. 39 for Pit and Fissure Sealants.

This looks like a 510(k) premarket notification for a dental sealant (Pulpdent Seal-Rite™ UDMA). The requested information regarding acceptance criteria, study details, and AI/human performance is not applicable to this document.

This document is focused on demonstrating substantial equivalence to legally marketed predicate devices, not on proving clinical effectiveness through novel performance studies. The "Safety and Effectiveness" section directly refers to existing knowledge about the material type (composites and glass ionomers) from a NIH conference, rather than presenting a specific study for this particular device.

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