(15 days)
3Delta UNlimited is a light-curing dental resin for restoring or improving chewing function by prosthetically
- reconstructing damaged or missing teeth using additively fabricated
- permanent full crowns, veneers, inlays, onlays
- temporary crowns & bridges (max. two consecutive pontics)
- monolithic full and partial dentures
- artificial denture teeth
3Delta UNlimited is a light-curing dental resin.
The provided text is a 510(k) clearance letter from the FDA for a dental resin device named "3Delta UNlimited." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is an administrative notification of clearance rather than a technical report detailing performance testing.
§ 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.