# K083326: Fluorocore 2

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Feb 10, 2009 after 90 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: 2 generations back to K940459 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896564: Dental Core Material, Dentsply Intl. (1990) Summary page 1.
- K040906: Calibra Cement, Dentsply Intl. (2004) Summary page 1.

## Most influential descendants
- K101504: TI-Core Flow (2010), 0 descendants of its own

## Indications for use
FluoroCore® 2 is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure) as a base prior to fabricating an indirect restoration and as a post cement.

Source page: https://510kreport.com/device/K083326
Methodology: https://510kreport.com/methodology