(184 days)
Pac-Dent Denture Base resin is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins.
Pac-Dent Denture Base resin is a light-curable resin.
The provided text is a clearance letter from the FDA for a dental device, specifically a "Pac-Dent Denture Base Resin." It does not contain information about the acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is strictly a regulatory clearance for a physical medical device (denture resin), not a software or AI-driven device.
Therefore, I cannot answer the questions regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies for an AI/ML device, as this information is not present in 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.