(45 days)
Quadrant Anterior Shine is a light curing dental composite filling material used in the adhesive restorative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue. Quadrant Anterior Shine is especially designed for the restoration of anterior teeth: a composite for aesthetic and cosmetic dentistry.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental filling material called "Quadrant Anterior Shine." This document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the letter does not contain any information about:
- Acceptance criteria or reported device performance metrics.
- Details of any study that proves the device meets specific acceptance criteria.
- Sample sizes (test or training sets).
- Data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance notification.
§ 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.