# K133608: Trinia

- Pathway: 510(k) (Abbreviated)
- Applicant: Bicon, LLC
- Decided: Mar 14, 2014 after 109 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
Longest line of descent: 1 generation back to K121735 (2013). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121735: Fiber Disk and Block Permanent, Trinia, Bioloren S.R.L. (2013) Summary page 1.

## Most influential descendants
- K152113: BioHPP - breCAM.BioHPP (2016), 3 descendants of its own
- K181484: Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue (2018), 0 descendants of its own
- K173124: PEEK Biosolution (2017), 0 descendants of its own
- K170102: Pekkton Ivory (2017), 0 descendants of its own

## Indications for use
Fiber Disks and Blocks (TRINIA) are milling blanks composed of a multi-directional interlacing of fiberglass and resin inseveral 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/K133608
Methodology: https://510kreport.com/methodology