CLEARFIL MAJESTY IC
K-Number: K182430 · 2019-05-03
ApplicantKuraray Noritake Dental, Inc.
Decision Date2019-05-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CLEARFIL MAJESTY IC is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-05-03 under approval number K182430. 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 CLEARFIL MAJESTY IC?
CLEARFIL MAJESTY IC is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K182430.
When was CLEARFIL MAJESTY IC approved by the FDA?
CLEARFIL MAJESTY IC received FDA 510(k) clearance on 2019-05-03, under approval number K182430.
What company makes CLEARFIL MAJESTY IC?
CLEARFIL MAJESTY IC is manufactured by Kuraray Noritake Dental, Inc..
What is the FDA product code for CLEARFIL MAJESTY IC?
The FDA product code for CLEARFIL MAJESTY IC is EBF.
Other Devices by Kuraray Noritake Dental, Inc.
K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
K153476KATANA AVENCIA Block
K170834CERABIEN ZR
K170986KATANA Zirconia Block
K191980CLEARFIL MAJESTY ES Flow
K191133KATANA Cleaner, KATANA Cleaner (Trial)
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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.