(87 days)
- Temporary anterior and posterior crowns with a wearing time of maximum three years
- Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years
- Verifying the fit on the plaster model/mouth before the final restoration
Ceramill A-Temp are ready to use, polymethyl methacrylate (PMMA) based computeraided manufacturing (CADCAM) blanks, for milling long-term temporary crowns and bridges and for verifying the fit on the plaster model/mouth before the final restoration is manufactured.
Ceramill A-Temp is available as a disk (round form) or as an arch-form (or "U"-shape) disk or as block shape blanks.
Here's a breakdown of the acceptance criteria and study information for the Ceramill A-Temp device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Requirement) | Ceramill A-Temp Performance | Comparison to Predicate Device |
|---|---|---|
| Residual monomer (ISO 10477:2018 requirement: 135 MPa | Similar to predicate (≥ 114 MPa); both exceed requirement. | |
| Water solubility (ISO 10477:2018 requirement: ≤ 7.5 µg/mm³) |
§ 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.