OMNICHROMA
K-Number: K173275 · 2018-02-27
ApplicantTokuyama Dental Corporation
Decision Date2018-02-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OMNICHROMA is a medical device manufactured by Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2018-02-27 under approval number K173275. 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?
OMNICHROMA is a medical device that received FDA 510(k) clearance on 2018-02-27. It is manufactured by Tokuyama Dental Corporation. The 510(k) number is K173275.
When was OMNICHROMA approved by the FDA?
OMNICHROMA received FDA 510(k) clearance on 2018-02-27, under approval number K173275.
What company makes OMNICHROMA?
OMNICHROMA is manufactured by Tokuyama Dental Corporation.
What is the FDA product code for OMNICHROMA?
The FDA product code for OMNICHROMA 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.