(38 days)
LC MICROFILL is a light cure microfill composite for tooth fillings (see enclosed Instruction for Use, MSDS).
LC MICROFILL is a light cure microfill composite for tooth fillings. The chemical composition and use of the LC MICROFILL material is the same as the material of RE-NAMEL of COSMEDENT, INC.
I am sorry, but the provided text describes a 510(k) submission for a dental filling material (LC MICROFILL) and a letter from the FDA indicating its substantial equivalence to a legally marketed predicate device.
This document does NOT contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
The 510(k) summary only states that the product's intended use, performance, indications, proposed labels, and instructions for use are "substantially similar" to a predicate device (RE-NAMEL by COSMEDENT, INC.). This means the FDA has determined it is safe and effective enough to be marketed based on its similarity to an already approved product, rather than requiring extensive de novo studies with detailed performance data as would be found in a Premarket Approval (PMA) submission.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document simply confirms the approval of the device based on substantial equivalence.
§ 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.