# K203598: Omnichroma Flow Bulk

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Feb 3, 2021 after 56 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: 5 generations back to K002863 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161353: ESTELITE BULK FILL Flow, Tokuyama Dental Corporation (2017) Summary page 6.
- K193537: Omnichroma Flow, Tokuyama Dental Corporation (2020) Summary page 6.

## Indications for use
For use as a tooth shade resin material in dental procedures such as: - Direct anterior and posterior restorations - Cavity base or liner - Blocking out cavity undercuts before fabricating indirect restorations - Repair of porcelain/composite

Source page: https://510kreport.com/device/K203598
Methodology: https://510kreport.com/methodology