Search Results

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.

Ask a specific question about this device

Fiber Disks and Blocks are milling blanks composed of a multidirectional interlacing of fiberglass and resin in several layers. They are intended to be used solely by professional dental technicians or dentists for making long-term temporary crowns, bridgework for one or two pontics, single tooth restorations, frameworks for particular patients, and substructures for anterior and posterior regions.

Fiber Disks and Blocks are milling blanks composed of a multidirectional interlacing of fiberglass and resin in several layers.

The provided text is a 510(k) premarket notification letter from the FDA regarding "Fiber Disks and Blocks" for use in dental restorations. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it would be relevant to an AI/ML medical device.

The letter is a regulatory approval for the device based on its substantial equivalence to a legally marketed predicate device, not on specific performance metrics or clinical study results that would typically be associated with AI/ML device evaluations. Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device