(49 days)
PermaCem® is a compomer based permanent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients.
Not Found
I am sorry, but based on the provided text, I cannot provide the detailed information required for the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental luting cement system (PermaCem® Automix Luting Cement System).
This type of letter primarily indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device, meaning it can be marketed. It does not present the detailed acceptance criteria, device performance results, study design, or ground truth establishment that would be found in a clinical study report or a more comprehensive premarket submission.
The document mentions:
- Device Name: PermaCem® Automix Luting Cement System
- Indications for Use: "PermaCem® is a compomer based permanent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients."
- Regulatory Class: II
- Product Code: EBF
- Date: July 10, 1998
To answer your specific questions, I would need access to the actual premarket submission (510(k) file) or a summary of the clinical/performance data submitted to the FDA for this device, which is not contained within these pages.
§ 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.