(76 days)
GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below:
GRADIA DIRECT ANTERIOR:
- Direct restorative for Class III, IV and V cavities.
- Direct restorative for wedge-shaped defects and root surface cavities.
- Direct restorative for veneers and diastema closure.
GRADIA DIRECT POSTERIOR:
- Direct restorations for Class I and II cavities.
visible light-cured micro-filled hybrid resin
The provided text is a 510(k) summary from the FDA for a dental restorative material named "Gradia Direct." This document is a clearance letter, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, the document does not contain any information regarding:
- Acceptance criteria and reported device performance (in a quantifiable, study-driven manner)
- Sample sizes used for test sets or their data provenance
- Number of experts or their qualifications for establishing ground truth
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance studies
- Type of ground truth used (expert consensus, pathology, outcomes data) for performance evaluation
- Sample size for training sets
- How ground truth for training sets was established
This document is solely an FDA clearance letter indicating that the device can be legally marketed based on its substantial equivalence to pre-existing devices, rather than comprehensive performance data from a specific study.
§ 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.