(169 days)
BEAUTIFIL II Enamel is a light-cured radiopaque restorative material, designed for anterior restorations as well as posterior restorations including for restorations involving occlusal surfaces. It can also be used for repair of restorations and prostheses.
(Indications)
· Direct anterior and posterior restorations (except for tooth root)
· Repair of restorations and prostheses
BEAUTIFIL II Enamel is a light-cured radiopaque restorative material.
This document is a 510(k) clearance letter from the FDA for a dental restorative material, not an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies typically associated with AI/ML device evaluations.
The document mainly focuses on:
- Device Name: Beautifil II Enamel
- Regulation Number: 21 CFR 872.3690
- Regulation Name: Tooth shade resin material
- Regulatory Class: II
- Product Code: EBF
- Indications for Use: Direct anterior and posterior restorations (except for tooth root), and repair of restorations and prostheses.
- FDA Determination: Substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information for acceptance criteria and study data because this document pertains to a traditional medical device (dental filling material) and does not involve AI/ML technology or associated performance studies in the context of diagnostic or prognostic capabilities.
§ 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.