(55 days)
The intended use of Kerr Hard Denture Reline Material is for the restoration of function and form in dentures which have become ill-fitting due to alveolar bone loss over a period of time.
The device is a paste/paste methacrylate based system for restoring function, comfort and esthetics to ill-fitting dentures. The system can be used either in the dental office or in the dental laboratory for relining of dentures.
The provided document is a 510(k) Summary for a dental device (Kerr Hard Denture Reline Material) and an FDA clearance letter. It does not describe a study involving an AI model or a device that uses AI. Therefore, I cannot extract information about acceptance criteria, study details, expert involvement, or AI performance metrics as requested.
The document discusses the substantial equivalence of the Kerr Hard Denture Reline Material to a legally marketed predicate device (Kooliner, GC America) based on similar function and intended use. This is a common regulatory pathway for medical devices that are not "AI-based."
§ 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.