# K193537: Omnichroma Flow

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Aug 19, 2020 after 243 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 K010267 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173275: Omnichroma, Tokuyama Dental Corporation (2018) Summary page 6.

## Most influential descendants
- K203598: Omnichroma Flow Bulk (2021), 0 descendants of its own

## Indications for use
The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/composite.

Source page: https://510kreport.com/device/K193537
Methodology: https://510kreport.com/methodology