(184 days)
For anterior and limited posterior restorations and sealings in dentistry
A flowable light cure microhybrid composite for tooth filling, sealing and cementing.
Stick™ Flow is a flowable composite with excellent color stability. It is flowable, aesthetic, abrasion resistant, strongly radiopaque and high gloss polish able.
The provided text {0} only mentions a 510(k) summary, device description, and intended use as part of a premarket notification for a dental composite material. It then states that the device is "substantially equivalent" to a previously approved device (Aeliteflo™, K955292). The subsequent text {1, 2, 3} consists of an FDA letter approving the 510(k) notification, confirming substantial equivalence, and specifying the indications for use.
Crucially, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically not included in the brief type of 510(k) summary provided here.
Therefore, I cannot fulfill the request to build the table and answer the questions based on the given input, as the necessary information is absent. The document focuses on regulatory approval based on substantial equivalence, not on detailed performance study results.
§ 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.