(29 days)
BEAUTIFIL Flow is a radiopaque, light cured fluoride releasing flowable restorative material for esthetic restoration intended for use in anterior restoration involving class III, class IV, class V (such as cervical caries, root surface caries, and wedge shaped defects), small posterior restoration (class I and II) without occlusal stress bearing, and restoration of deciduous.
BEAUTIFIL Flow is a radiopaque, light cured fluoride releasing flowable restorative material for esthetic restoration.
The provided text is a 510(k) premarket notification document for a dental device named "BEAUTIFIL Flow." It is a letter from the FDA to Shofu Dental Corporation confirming the substantial equivalence of the device to legally marketed predicate devices.
This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
Instead, it is a regulatory approval document based on the device being substantially equivalent to existing devices. Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a detailed study as this data is not present in the provided text.
The document primarily focuses on:
- The FDA's decision regarding the 510(k) submission.
- The classification of the device (Class II).
- General controls and regulations applicable to the device.
- Indications for Use for "BEAUTIFIL Flow."
To answer your request, information about a specific study, including acceptance criteria, sample sizes, ground truth establishment, and expert involvement, would need to be present in a performance data section of a 510(k) submission or a separate clinical/non-clinical study report, which is not included here.
§ 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.