# K143524: Fiber Disks and Blocks (TRINIA)

- Pathway: 510(k) (Traditional)
- Applicant: Bicon, LLC
- Decided: Jun 2, 2015 after 172 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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).

Source page: https://510kreport.com/device/K143524
Methodology: https://510kreport.com/methodology