(188 days)
KeyPrint KeyDenture Base is a photopolymer resin indicated for the 3D fabrication of denture bases, including full and partial removable dentures, in dental laboratories. Fabrication requires a computer-aided design and manufacturing (CAD/CAM) system and 3D printer.
KeyPrint KeyDenture Base is designed for additive manufacturing in vat polymerization 3D printers utilizing wavelengths between 385nm-405nm. KeyDenture Base is indicated for the fabrication of oral denture appliances for fully and partially edentulous patients. KeyDenture Base is intended to be used within a computer-aided and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, and post-cure unit. For any components that are used in conjunction with the KeyDenture Base resin, the user should review all applicable product labeling including Instructions for Use, user manuals, and other associated labeling. Strict adherence to all labeling is critical in assuring a safe and effective printed appliance.
The provided document is a 510(k) Summary for the KeyPrint KeyDenture Base. It details the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. There is no information about an AI/ML device in this document. Thus, I cannot fulfill the request as it relies on information about AI/ML device performance which is not present.
§ 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.