(90 days)
"Light-Activated Low-Stress Thiol-Ene Composite Restorative Material" is a light Cure restorative material indicated for direct esthetic restoration of anterior and posterior teeth. It provides easy esthetics since it is formulated in shades matching the VITA Lumin® Shade guide. This low stress nanohybrid composite can be used in all classes of direct dental restorations, Class I, II, III, IV, and V. It may also be used for dental core build-ups
Light-Activated Low-Stress Thiol-Ene Composite Restorative Material
The provided text is a cover letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about a study, as this information is not present in the provided document.
The document primarily focuses on:
- Confirming the substantial equivalence of the device to legally marketed predicate devices.
- Outlining the regulatory requirements that the manufacturer must comply with.
- Stating the intended use of the device ("Light-Activated Low-Stress Thiol-Ene Composite Restorative Material" indicated for direct esthetic restoration of anterior and posterior teeth, and for dental core build-ups).
§ 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.