(60 days)
This material is intended for extended pit and fissure sealing; class V restoration, minimal invasive restorations of class I, II and III; slight form and shade corrections of enamel; splinting of teeth after traumatic impact; adjustments of congenital tooth defects (e.g. enamel hypoplasis); cavity lining in class I and II restorations.
Not Found
This document is a 510(k) premarket notification from the FDA, approving a dental device called "Flow Line." It does not contain information about acceptance criteria, device performance studies, or details relevant to the specific questions posed (sample sizes, expert qualifications, ground truth, etc.). This type of FDA letter confirms that a device is substantially equivalent to a predicate device, allowing it to be marketed, but does not typically include the detailed study results that would satisfy your request.
Therefore, I cannot extract the requested information from 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.