(139 days)
Nic Tone Acrylic Resins are used in the fabrication, repair or rebasing of complete or partial removable dentures, the fabrication of veneer crowns, the fabrication of orthodontic devices, and the fabrication of temporary crowns and bridges.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) premarket notification letter from the FDA regarding "Nic Tone Acrylic Resins," confirming its substantial equivalence to legally marketed predicate devices. It discusses regulatory classifications, general controls, and responsibilities of the manufacturer but does not delve into specific performance studies or acceptance criteria for the device itself.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.