(125 days)
Protech's Plus and Soft Reline resins are intended to be used for relining a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for a dental device, "ProTech Plus." It does not contain any information about acceptance criteria, device performance studies, or data provenance related to AI/ML devices.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this document pertains to a traditional medical device (denture relining, repairing, or rebasing resin) and not an AI-powered device.
The letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.
§ 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.