Bluephase PowerCure
K-Number: K190272 · 2019-07-03
ApplicantIvoclar Vivadent, AG
Decision Date2019-07-03
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bluephase PowerCure is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-07-03 under approval number K190272. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bluephase PowerCure?
Bluephase PowerCure is a medical device that received FDA 510(k) clearance on 2019-07-03. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K190272.
When was Bluephase PowerCure approved by the FDA?
Bluephase PowerCure received FDA 510(k) clearance on 2019-07-03, under approval number K190272.
What company makes Bluephase PowerCure?
Bluephase PowerCure is manufactured by Ivoclar Vivadent, AG.
What is the FDA product code for Bluephase PowerCure?
The FDA product code for Bluephase PowerCure is EBZ.
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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.