(71 days)
Heliomolar HB is a light-curing, radiopaque microfilled composite specifically designed for posterior restorations. The Translucent shades are to be used as a top lor the restoration to further enhance the esthetic appearance.
Heliomolar HB is a light-curing, radiopaque microfilled composite specifically designed for posterior restorations. The Translucent shades are to be used as a top lor the restoration to further enhance the esthetic appearance.
The provided text is a set of FDA correspondence letters and a form. It does not contain any information about acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert qualifications for a medical device.
The document is a 510(k) premarket notification letter for a dental composite filling material, "Heliomolar HB Translucent Shades" (K013929). It confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details from the provided text.
§ 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.