BRILLIANT EverGlow Flow
K-Number: K190597 · 2019-06-21
ApplicantColtene/Whaledent AG
Decision Date2019-06-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BRILLIANT EverGlow Flow is a medical device manufactured by Coltene/Whaledent AG. It received FDA 510(k) clearance on 2019-06-21 under approval number K190597. 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 BRILLIANT EverGlow Flow?
BRILLIANT EverGlow Flow is a medical device that received FDA 510(k) clearance on 2019-06-21. It is manufactured by Coltene/Whaledent AG. The 510(k) number is K190597.
When was BRILLIANT EverGlow Flow approved by the FDA?
BRILLIANT EverGlow Flow received FDA 510(k) clearance on 2019-06-21, under approval number K190597.
What company makes BRILLIANT EverGlow Flow?
BRILLIANT EverGlow Flow is manufactured by Coltene/Whaledent AG.
What is the FDA product code for BRILLIANT EverGlow Flow?
The FDA product code for BRILLIANT EverGlow 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.