(16 days)
A temporary lining for acrylic dentures. For use in chair-side procedures.
Not Found
This document is a 510(k) premarket notification approval letter for a dental device called "Coe Soft" (K070697). It's a regulatory document from the FDA, not a study report detailing acceptance criteria for an AI/software device.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/software device is not present in this document.
This document primarily indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory standard for medical devices, not a performance standard established through a clinical or algorithmic study.
§ 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.