Omnichroma Flow
K-Number: K193537 · 2020-08-19
ApplicantTokuyama Dental Corporation
Decision Date2020-08-19
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Omnichroma Flow is a medical device manufactured by Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2020-08-19 under approval number K193537. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Omnichroma Flow?
Omnichroma Flow is a medical device that received FDA 510(k) clearance on 2020-08-19. It is manufactured by Tokuyama Dental Corporation. The 510(k) number is K193537.
When was Omnichroma Flow approved by the FDA?
Omnichroma Flow received FDA 510(k) clearance on 2020-08-19, under approval number K193537.
What company makes Omnichroma Flow?
Omnichroma Flow is manufactured by Tokuyama Dental Corporation.
What is the FDA product code for Omnichroma Flow?
The FDA product code for Omnichroma Flow is EBF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.