(112 days)
Restoration of Class V cavities and cervical abrasion lesions, restoration of Class III cavities, restoration of Class I and II cavities of deciduous molars and miscellaneous restorative repairs.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called "FREEDOM." This document confirms that the device is substantially equivalent to a legally marketed predicate device for specific indications for use (restoration of various classes of cavities and restorative repairs).
However, this letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any details about a study to prove the device meets acceptance criteria. It is a regulatory approval document, not a scientific study report.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the information provided in this document.
§ 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.