(41 days)
AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. AuraLay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. Aural.ay is available in different fluoride concentrations for different patient use.
AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. Aural ay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. AuraLay is available in different fluoride concentrations for different patient use.
The provided text is a 510(k) premarket notification for the "AuraLay Pit & Fissure Sealant." This type of submission is a claim of substantial equivalence to a legally marketed predicate device, rather than a submission that presents de novo clinical study data to demonstrate safety and effectiveness.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, or specific performance metrics from a dedicated clinical study.
Instead, the submission relies on the following:
- Substantial Equivalence: The core of this document is the claim that AuraLay Pit & Fissure Sealant is substantially equivalent in design, composition, performance, intended use, and effectiveness to existing predicate devices (CosmeSeal Pit and Fissure Sealant, UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit, and Delton Clear Pit and Fissure Sealant Kit).
- Predicate Device Performance: The safety and effectiveness are supported by the track record of these predicate devices, which have been found to be substantially equivalent themselves and have been in general usage for about 30 years with a "high benefit-to-risk ratio" and no evidence of short-term or long-term risk.
- NIH Technology Assessment: A reference is made to an NIH Technology Assessment conference regarding "Effects and Side-Effects of Dental Restorative Materials," which states that such materials are "relatively trouble-free" and have "no suspicion of any problems after virtually billions of procedures in the United States."
In summary, there is no direct study described in this document that establishes specific acceptance criteria for the AuraLay Pit & Fissure Sealant and then demonstrates its performance against those criteria using a dedicated test set, ground truth, or statistical analysis (e.g., MRMC or standalone performance). The approval is based on equivalence to already approved and widely used devices.
§ 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.