(320 days)
Microhybrid Composite is indicated for direct esthetic restoration in the anterior and posterior regions. This composite can be used in all direct dental restorations, Class i, II, III, IV, and V, and diastema closure.
Microhybrid Composite
The provided text is a 510(k) premarket notification letter from the FDA for a dental device called "Microhybrid Composite." It discusses the regulatory approval process and general compliance requirements. However, this document does not contain the specific information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or human-in-the-loop performance.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. This type of submission (510(k)) generally relies on demonstrating substantial equivalence rather than presenting extensive de novo clinical study data with detailed acceptance criteria and performance metrics like those typically required for novel AI/ML devices or higher-risk devices.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information because it is not present in the provided document. The document focuses on regulatory approval based on substantial equivalence, not on the detailed results of a performance study demonstrating specific acceptance criteria.
§ 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.