Omnichroma Flow— 510(k) K193537

Substantially Equivalent

Tokuyama Dental Corporation

FDA 510(k) clearance K193537 for Omnichroma Flow, Substantially Equivalent on 2020-08-19. Applicant: Tokuyama Dental Corporation. Device class: 2.

Clearance details

Applicant: Tokuyama Dental Corporation
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2019-12-20
Decision date: 2020-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Tokuyama Dental Corporation

K203760 — Tokuyama Universal Bond II2021-05-25
K203598 — Omnichroma Flow Bulk2021-02-03
K190940 — Tokuyama Rebase III2019-10-04
K180613 — Estelite Universal Flow2018-07-12
K173275 — OMNICHROMA2018-02-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.