(54 days)
The two paste system, when combined in approximately equal portions of universal and catalyst, will auto-polymerize to form a hard, radiopaque material for anterior restorations and core buildups.
SELF CURE COMPOSITE
The provided text is a 510(k) clearance letter from the FDA for a dental product called "Self Cure Composite." This type of document does not typically contain acceptance criteria or a study description in the way that a software or AI/ML device submission would.
The letter focuses on the FDA's determination of substantial equivalence to a previously marketed predicate device. This means the manufacturer demonstrated that their device performs as intended and is as safe and effective as a device already legally on the market. The FDA letter approves the device based on this comparison, rather than detailing specific performance metrics and a study that proves they are met.
Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, ground truth establishment, etc.) from this document. The provided text is a regulatory approval document, not a scientific study report or performance evaluation.
§ 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.