(85 days)
TurboTemp EZ is a is a self-cure crown-and-bridge composite indicated for the fabrication of long- and short-term provisional restorations including veneers, inlays/onlays, crowns, bridges and long-span bridges. TurboTemp EZ is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or a partial denture.
TurboTemp EZ is a provisional resin based material intended to be used for the fabrication of crowns, bridges, inlays, onlays, and veneers. The composite material is provided in a dual-barrel cartridge that when combined in the mixing tip, it is dispensed as a self-curing restorative material.
The provided text describes the regulatory clearance of a dental device, "TurboTemp EZ," and includes information relevant to its performance testing and comparison to predicate devices, rather than a study proving the device meets acceptance criteria in terms of algorithm performance for an AI/ML device.
Based on the content provided, here's an analysis structured according to your request, with the understanding that this is for a physical medical device, not an AI/ML algorithm:
1. A table of acceptance criteria and the reported device performance
For a physical dental material, acceptance criteria often relate to physical, chemical, and biological properties, usually benchmarked against industry standards or predicate devices.
| Acceptance Criteria (from predicate/standards) | Reported Device Performance (TurboTemp EZ) |
|---|---|
| Transverse Strength (Typically >= 100 MPa from predicate/standards) | 94 MPa |
| Water Sorption (Typically |
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.