(53 days)
CAD-Temp is used for the fabrication of multi-unit, full or partial anatomical long term temporary bridge restorations with up to 2 pontics using the inLab or CEREC systems of Sirona. The bridge block can also be used for temporary crowns. The Vita CAD-Temp acrylic polymer blocs are available in the four shades 0M1T, 2M2T, 3M2T, and 4M2T and in the size CT-40 (15.5 x 19 x 39 mm).
Vita CAD-Temp acrylic polymer blocs are available in the four shades 0M1T, 2M2T, 3M2T, and 4M2T and in the size CT-40 (15.5 x 19 x 39 mm).
The provided document is a 510(k) clearance letter from the FDA for the device "Vita CAD-Temp for inLab®". It indicates that the device has received substantial equivalence to a legally marketed predicate device. However, this letter does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about device performance metrics, sample sizes, ground truth establishment, or clinical study designs (MRMC or standalone).
The letter focuses on the regulatory clearance for marketing the device as a "Temporary Crown and Bridge Resin" with specific indications for use: "fabrication of multi-unit, full or partial anatomical long term temporary bridge restorations with up to 2 pontics using the inLab or CEREC systems of Sirona. The bridge block can also be used for temporary crowns."
Therefore, I cannot provide the requested information. The document primarily confirms regulatory approval based on substantial equivalence, not detailed performance study data.
§ 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.