(16 days)
· Direct anterior and posterior restorations (including occlusal surfaces)
· Core build-ups
· Splinting
· Indirect restorations including inlays, onlays, and veneers
3MTM FiltekTM Universal Restorative, is a visible-light activated, restorative composite optimized to create esthetic anterior and posterior restorations. This material provides excellent strength and low wear for durability and improved esthetics with higher level of visual opacity. The shades are body like opacity enabling up to a 2mm depth-of-cure. The pink opaquer can be placed in 1mm thick increments. All shades are radiopaque. Filtek Universal Restorative is offered in the following shades: A1. A2, A3. A3.5. A4, B1. B2, D3. XW, and PO. The pink opaque shade option can be used to mask discolored or stained tooth structure.
Filtek™ Universal Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser. Capsules may be warmed up to 70°C/158°F for one hour in a commercial warmer prior to use.
This document is a 510(k) summary for a dental restorative material, not an AI/ML medical device. Therefore, it does not contain the information required to answer the prompt regarding AI model performance, acceptance criteria, or specific study details like MRMC comparative effectiveness studies, ground truth establishment for AI training/test sets, or expert qualifications for reviewing AI outputs.
The document primarily focuses on establishing substantial equivalence to a predicate device based on material composition, physical properties, and intended use for a traditional dental restorative. It outlines typical material property tests (e.g., Compressive Strength, Depth of Cure) for dental composites.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.