BRILLIANT COMPONEER
K-Number: K191385 · 2019-10-29
ApplicantColtene/Whaledent AG
Decision Date2019-10-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BRILLIANT COMPONEER is a medical device manufactured by Coltene/Whaledent AG. It received FDA 510(k) clearance on 2019-10-29 under approval number K191385. 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 COMPONEER?
BRILLIANT COMPONEER is a medical device that received FDA 510(k) clearance on 2019-10-29. It is manufactured by Coltene/Whaledent AG. The 510(k) number is K191385.
When was BRILLIANT COMPONEER approved by the FDA?
BRILLIANT COMPONEER received FDA 510(k) clearance on 2019-10-29, under approval number K191385.
What company makes BRILLIANT COMPONEER?
BRILLIANT COMPONEER is manufactured by Coltene/Whaledent AG.
What is the FDA product code for BRILLIANT COMPONEER?
The FDA product code for BRILLIANT COMPONEER 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.