(64 days)
For relining and rebasing dentures.
Not Found
This document is a 510(k) clearance letter from the FDA for the "A-Soft Reliner" device. It is a traditional medical device submission and therefore does not contain information about AI/ML acceptance criteria or studies. The letter indicates that the device is for "relining and rebasing dentures" and has been found substantially equivalent to a predicate device.
Therefore, I cannot provide the requested information regarding AI/ML clinical studies, acceptance criteria, sample sizes, ground truth establishment, or expert details, 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.