(49 days)
This product is a light-cured micro-filled composite resin for use in the following recommended indications: Direct restorative for Class I and II cavities.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Gradia Direct X." This document is a regulatory approval, not a scientific study report. It states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the approval is based on a comparison to existing devices, not a new study demonstrating performance against specific acceptance criteria in the manner requested.
§ 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.