(111 days)
Grandio Flow is intended for the following applications:
- filling minimally invasive cavities of all classes -
- filling small class I cavities and extended fissure sealing -
- filling class II-V cavities including V-shaped defects and cervical caries -
- blocking out undercuts -
- lining or coating cavities -
- repairing fillings and veneers -
- luting translucent prosthetic pieces (e.g. full ceramic crowns, etc.) -
Not Found
The provided document is an FDA 510(k) clearance letter for a dental resin material (Grandio Flow). It is not a study report or clinical trial documentation for an AI/CADe/CADx device. Therefore, it does not contain any of the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement for such studies.
The document indicates that the device Grandio Flow is a "Tooth Shade Resin Material" and is classified as "Regulatory Class: II" with product code "EBF". The 510(k) clearance states that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance for this product category does not typically involve the kind of performance studies with acceptance criteria, ground truth, and expert review that would be conducted for a diagnostic AI device.
Therefore, I cannot extract the requested information from this document.
§ 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.