# K101504: TI-Core Flow

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Oct 29, 2010 after 150 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940459 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083326: Fluorocore 2, Dentsply International, Inc. (2009) Summary page 1.
- K053040: Paracem Universal DC, Coltene/Whaledent AG (2005) Summary page 1.
- K922251: TI-Core-Natural, Essential Dental Systems, Inc. (1994) Summary page 1.

## Indications for use
Ti-Core® Flow+ 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. Ti-Core® Flow+ is also indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, and for core build-ups.

Source page: https://510kreport.com/device/K101504
Methodology: https://510kreport.com/methodology