(141 days)
Zenith Flowable Composite is a tooth-shaded resin filling material for use as an esthetic anterior restoration or mase restoration under posterior or anterior composites.
Zenith Flowable Composite is a tooth-shaded resin filling material.
The provided text is a 510(k) premarket notification letter from the FDA to a dental device manufacturer. It confirms the substantial equivalence of the "Zenith Flowable Composite" to a legally marketed predicate device.
This document does NOT contain information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth or conduct clinical trials.
Therefore, I cannot answer your request for the following reasons:
- No acceptance criteria or device performance data is present. The letter is a regulatory approval and does not detail performance metrics.
- No study information is provided. It does not describe any clinical trials, validation studies, or the data collected from such studies.
- No ground truth establishment methods are mentioned.
- No information on sample sizes, expert qualifications, or adjudication methods is available.
- No details on standalone performance or MRMC studies are included.
- No training set information is provided.
The document is purely administrative, confirming the device's marketability based on its substantial equivalence to a pre-existing device. If your query relates to the regulatory process for proving substantial equivalence, then the document confirms that the device was deemed substantially equivalent based on information submitted in the 510(k) application (K970683). However, it does not provide the specifics of that information regarding performance studies.
§ 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.