(109 days)
Fiber Disks and Blocks (TRINIA) 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 copings, substructures, removable dentures, 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).
TRINIA is a fiber machining disk block. It is made of layers of glass fibers kept together by epoxy resin. TRINIA products are designed for the manufacturing of non-metallic dental appliances. The dental appliance is machined either by a CAD/CAM machine or by using the copying technique. TRINIA already possesses the mechanical characteristics needed for producing these dental appliances; no curing is necessary at the dental lab to make the product function properly.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TRINIA dental device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes acceptance criteria by demonstrating that TRINIA's physical properties and biocompatibility are comparable to or exceed those of the predicate device. For some tests, direct comparison to the predicate is available, while for others, the "acceptance criteria" can be inferred to be the reported result itself, as these values demonstrate the device's inherent mechanical and biological characteristics, which are deemed acceptable.
| Test Name | Acceptance Criteria (Predicate or Implicit) | Reported Device Performance (TRINIA) | Units |
|---|---|---|---|
| Flexural strength | ≥ 302 MPa (Predicate) | 393 | MPa (N/mm²) |
| Flexural strain at max stress |
§ 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.