(34 days)
Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. This oonlant is designed for filling of the classes I, II, and V according to Black. It also can be pred for splinting of teeth which are traumatically loose, restoration of primary teeth and reconstruction of stumps. It is available in the shades A1, A2, A3, A3, A3, A4, B2, B3, B4, C3, and Incisal.
Solitaire 2 is a light curing, fluoride releasing radio-opaque polyglass composite. It is available in the shades A1, A2, A3, A3, A3, A4, B2, B3, B4, C3, and Incisal.
The provided text is a letter from the FDA regarding the "Solitaire® 2" dental restoration device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device has been found substantially equivalent to devices marketed prior to May 28, 1976, allowing it to be marketed.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This document is a regulatory approval letter, not a scientific study report or performance evaluation.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.