(21 days)
Quadrant Universal LC 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 Universal LC is a composite for universal use: the restoration of both anterior and posterior teeth.
Quadrant Universal LC is a light curing dental composite filling material.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental composite filling material named "Quadrant Universal LC." It confirms that the device is substantially equivalent to a previously marketed device.
The document discusses:
- The FDA's review of the 510(k) notification.
- The substantial equivalence determination.
- Regulatory classifications and requirements for the device.
- Contact information for various FDA offices.
- The device's indications for use.
It does not include details about:
- A table of acceptance criteria or reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
Therefore, I cannot answer your request based on the provided text.
§ 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.