(138 days)
NextDent Jet Denture Base is a light curing resin intended for 3D printing of a full or partial denture base to form a denture. The product, when used in combination with NextDent Jet Denture Teeth can be used for 3D printing a removable full or partial denture. For dental professional use only.
NextDent Jet Denture Teeth is a light curing resin intended for the 3D printing of artificial teeth to form a denture, temporary crowns or bridges. The product, when used in combination with NextDent Jet Denture Base can be used for 3D printing a removeable full or partial denture. For dental professional use only.
NextDent Jet Denture resins are pre-mixed combinations of acrylate-based light-cure resins with pigments, polymerized via photo initiators in a 3D printer setting for the fabrication of full or partial denture bases and artificial teeth to form a denture and for the fabrication of temporary crowns or bridges. The resins must be used in combination with 3D Systems printers that support MultiJet Printing technology. Devices are produced in an automated additive manufacturing method where ultra-thin layers of photopolymer material are jetted onto a build tray. Immediately after being jetted, each photopolymer layer is cured by UV light. The process repeats layer by layer until the 3D part is complete. Upon completion the support material is removed, and the product is cleaned. When printing a denture base, bonding of artificial teeth to the denture base is possible to form a denture. The bonding agent instructions should be followed. Printed parts are finished using conventional dental methods and instruments.
The provided text is a 510(k) Premarket Notification from the FDA for "NextDent Jet Denture Base" and "NextDent Jet Denture Teeth". It describes the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.
However, the provided text does not contain information related to an AI/ML device. Specifically, there is no mention of acceptance criteria for an AI algorithm, test set details, expert involvement in ground truth establishment, MRMC studies, or training set information. The testing described focuses on the mechanical and biocompatibility properties of the dental resins, adhering to ISO standards for dental materials.
Therefore, I cannot provide an answer that describes the acceptance criteria and the study proving an AI/ML device meets them based on the provided text. The questions posed in your prompt (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for AI, training set details) are relevant to AI/ML device evaluations but are not addressed in this document, as it pertains to a materials-based medical device.
§ 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.