Omnichroma Flow Bulk
K-Number: K203598 · 2021-02-03
ApplicantTokuyama Dental Corporation
Decision Date2021-02-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Omnichroma Flow Bulk is a medical device manufactured by Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2021-02-03 under approval number K203598. 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 Bulk?
Omnichroma Flow Bulk is a medical device that received FDA 510(k) clearance on 2021-02-03. It is manufactured by Tokuyama Dental Corporation. The 510(k) number is K203598.
When was Omnichroma Flow Bulk approved by the FDA?
Omnichroma Flow Bulk received FDA 510(k) clearance on 2021-02-03, under approval number K203598.
What company makes Omnichroma Flow Bulk?
Omnichroma Flow Bulk is manufactured by Tokuyama Dental Corporation.
What is the FDA product code for Omnichroma Flow Bulk?
The FDA product code for Omnichroma Flow Bulk 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.