(55 days)
Prodigy- 3 is a flowable, light cure hybrid resin restorative designed to be used as a filling material for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.
The device is a light cured, hybrid resin dental restorative which incorporates BIS-GMA chemistry along with a proprietary glass filler (approximately 55%) to vield a flowable nonslumping restorative material. Prodigy - 3's combination of flowability and direct application system simplifies material placement and minimizes finishing to result in a consistently superior restoration.
The provided text is a 510(k) summary for a dental restorative material named Prodigy-3. This document describes the device, its intended use, and its substantial equivalence to a predicate device (Kerr Corporation, Revolution).
However, the provided text does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria. It is a regulatory submission focused on demonstrating substantial equivalence to an already marketed device, not on presenting performance data from a specific study against acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document's purpose is to state that Prodigy-3 is substantially equivalent to existing devices, implying that its performance is expected to be comparable, not to detail new performance studies against explicit acceptance criteria.
§ 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.