(54 days)
FLOWABLE LIGHT CURE COMPOSITE: This fluid composite will flow into difficult areas and therefore indicates its use for Class V and Class III restorations.
Not Found
The provided documents (FDA 510(k) clearance letter and Indications for Use) do not contain information regarding
acceptance criteria for device performance, a study to prove acceptance criteria, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.
The documents primarily focus on the regulatory clearance for the "FLC Composite" device based on its substantial equivalence to a legally marketed predicate device. The Indications for Use section only specifies the intended clinical applications for the device (Class V and Class III restorations due to its flowable nature).
Therefore, I cannot provide the requested information based on the input.
§ 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.