KATANA Zirconia Block
K-Number: K190436 · 2019-05-23
ApplicantKuraray Noritake Dental, Inc.
Decision Date2019-05-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
KATANA Zirconia Block is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-05-23 under approval number K190436. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KATANA Zirconia Block?
KATANA Zirconia Block is a medical device that received FDA 510(k) clearance on 2019-05-23. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K190436.
When was KATANA Zirconia Block approved by the FDA?
KATANA Zirconia Block received FDA 510(k) clearance on 2019-05-23, under approval number K190436.
What company makes KATANA Zirconia Block?
KATANA Zirconia Block is manufactured by Kuraray Noritake Dental, Inc..
What is the FDA product code for KATANA Zirconia Block?
The FDA product code for KATANA Zirconia Block is EIH.
Other Devices by Kuraray Noritake Dental, Inc.
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K153476KATANA AVENCIA Block
K170834CERABIEN ZR
K170986KATANA Zirconia Block
K191980CLEARFIL MAJESTY ES Flow
K191133KATANA Cleaner, KATANA Cleaner (Trial)
Related Devices (Code: EIH)
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.