(43 days)
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.
Therefore, I cannot extract the information you requested because it is not present in the provided text.
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EXHIBIT 8
RESPONSE TO SMDA OF 1990
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA
TELEPHONE: (617) 926-6666 FAX: (617) 926-6262
Pulpdent Seal-Rite™ UDMA DEVICE NAME:
PREDICATE DEVICE:
Pulpdent Seal-Rite and Seal-Rite Low Viscosity Vivodent/Ivoclar Helioseal and HelioSeal-F Kulzer Estiseal Ultradent Ultra-Blend
Pulpdent Seal-Rite™UDMA is a radiopaque, DESCRIPTION AND INTENDED USE: 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.
COMPARISON WITH PREDICATE PRODUCTS: Pulpdent Seal-Rite™ UDMA is substantially equivalent in composition and/or intended use to the above mentioned predicate products. Please see EXHIBIT 5 for the entire comparison.
SAFETY AND EFFECTIVENESS: According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio... both composites and glass ionomers are relatively trouble free. There is no evidence of short or long term risk... there is no suspicion of any problems after literally billions of procedures in the United States." Please see EXHIBIT 6 for the complete papers from the conference.
§ 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.