Bluephase Style 20i
K-Number: K163613 · 2017-04-04
ApplicantIvoclar Vivadent, AG
Decision Date2017-04-04
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bluephase Style 20i is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2017-04-04 under approval number K163613. 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 Style 20i?
Bluephase Style 20i is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K163613.
When was Bluephase Style 20i approved by the FDA?
Bluephase Style 20i received FDA 510(k) clearance on 2017-04-04, under approval number K163613.
What company makes Bluephase Style 20i?
Bluephase Style 20i is manufactured by Ivoclar Vivadent, AG.
What is the FDA product code for Bluephase Style 20i?
The FDA product code for Bluephase Style 20i 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.