(52 days)
Grandio Seal is intended for sealing/filling of pits and fissures, sealing/facing of damaged enamel surfaces, covering of caries predilection sites during or damaged composite or coment fillings (redilection sites during orthodontic treatment, sealing of composite or cement filling of cance production sites uning of modeling of decident, sealing of deciduous teeth.
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I am sorry, but the provided text does not contain information about the acceptance criteria or any study details for the Grandio Seal device. The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It does not include performance data or clinical study results.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 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.