(78 days)
Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also used as a wetting agent prior to bonding resin fillings and composites.
Not Found
The provided document is an FDA 510(k) clearance letter for a dental desensitizer device. It does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.
The letter focuses on:
- Confirming that the device and its indications for use are substantially equivalent to a legally marketed predicate device.
- Outlining the regulatory requirements the manufacturer must comply with (e.g., registration, labeling, good manufacturing practice).
- Providing contact information for regulatory questions.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or expert qualifications from this document. This kind of information would typically be found in the 510(k) premarket notification submission itself, not in the clearance letter.
§ 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.