# K173275: Omnichroma

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Feb 27, 2018 after 138 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: 1 generation back to K010267 (2001). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K010267: Palfique Estelite LV Clear, Tokuyama America, Inc. (2001) Summary page 6.

## Most influential descendants
- K193537: Omnichroma Flow (2020), 1 descendant of its own
- K261071: DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) (2026), 0 descendants of its own
- K203598: Omnichroma Flow Bulk (2021), 0 descendants of its own

## Indications for use
For use as a tooth shade resin material in dental procedures, such as: - Direct anterior and posterior restorations - Direct bonded composite veneer - Diastema closure - Repair of porcelain/composite

Source page: https://510kreport.com/device/K173275
Methodology: https://510kreport.com/methodology