(86 days)
Heat curing polymer for dental prosthesis used for the repair and extending of dentures, relining for completing metal dentures and for use in orthodontia.
Not Found
I am unable to provide a description of the acceptance criteria and study as the provided document is a 510(k) clearance letter for a dental device (Dentorium Convertible Acrylic) and does not contain information about acceptance criteria or supporting studies. It primarily states that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.
The document discusses the regulatory classification, general controls, and compliance requirements for the device. It also includes an "Indications for Use" section (Page 2), which outlines what the device is intended for and its contraindications.
Therefore, I cannot extract the requested information from the provided text.
§ 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.