(253 days)
Fiber Disks and Blocks are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used solely by dental technicians and dentists for making only copings, substructures or frameworks for permanent and transitional anterior or posterior crowns, bridgework and substructures that can be for either cemented or uncemented restorations e.g., telescopic restorations.
Fiber Disks and Blocks are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers.
The provided text is a 510(k) premarket notification letter from the FDA to Bioloren Srl for a dental product called "Fiber Disk And Block Permanent, Trinia." This document does not describe acceptance criteria, a study that proves the device meets acceptance criteria, or any details about a study's methodology or outcomes.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing devices, not on specific performance data or study results.
§ 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.