(16 days)
- Fillings of any minimally invasive cavity
- Fillings of small cavities and extended fissure sealing
- Block out undercuts
- Lining or coating cavities
- Elling of couling vincluding V-shaped defects and cervical caries
- Repair of fillings and veneers
- Repair of filling of translucent prosthetic pieces, e.g., porcelain-only crowns
Not Found
This is a 510(k) premarket notification for a dental resin material, not an AI/ML powered device. As such, the information requested regarding acceptance criteria and studies proving device performance with respect to AI/ML specific metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.
The document discusses the substantial equivalence of the Grandio Flow dental resin to legally marketed predicate devices. The review process for such a device focuses on material properties, biocompatibility, and intended use, rather than AI/ML algorithm performance.
Therefore, I cannot provide the requested table and study details as they pertain to AI/ML devices.
§ 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.