(158 days)
Juell 3D Volo Base is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. Juell 3D Volo Base is intended exclusively for professional dental work. Fabrication of denture bases with Juell 3D Volo Base requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unit.
Juell 3D Volo Base 3D-printing material is a light-cured resin indicated for the manufacturing of denture bases. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printed product is placed in a UV-light curing box for final polymerization.
3D printer is not included with the device.
The provided text describes a 510(k) premarket notification for a dental device, Juell 3D Volo Base. The device is a light-cured resin intended for the fabrication of denture bases using a CAD/CAM system. The submission argues for substantial equivalence to a predicate device, NextDent Denture/E-Denture.
However, the provided document does not contain information about a study that describes acceptance criteria, device performance against those criteria, or details regarding expert involvement, ground truth establishment, or sample sizes related to AI/ML device testing.
The document discusses "Bench Testing" in the context of material properties (Flexural Strength, Flexural Modulus, Water Solubility, and Residual Monomer) and states that "All test were passed" in compliance with ISO 20795-1 Type 4 Material. It also mentions biocompatibility. This is standard for material-based devices, not for AI/ML performance.
Therefore, I cannot provide the specific information requested about acceptance criteria and a study proving an AI/ML device meets them based on the provided text. The device described (Juell 3D Volo Base) is a material, not an AI/ML system.
§ 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.