# K112186: Fiber Disk and Block

- Pathway: 510(k) (Traditional)
- Applicant: Bioloren S.R.L.
- Decided: Nov 8, 2011 after 102 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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 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.

Source page: https://510kreport.com/device/K112186
Methodology: https://510kreport.com/methodology