CERABIEN ZR
K-Number: K170834 · 2017-10-17
ApplicantKuraray Noritake Dental, Inc.
Decision Date2017-10-17
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CERABIEN ZR is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2017-10-17 under approval number K170834. 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 CERABIEN ZR?
CERABIEN ZR is a medical device that received FDA 510(k) clearance on 2017-10-17. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K170834.
When was CERABIEN ZR approved by the FDA?
CERABIEN ZR received FDA 510(k) clearance on 2017-10-17, under approval number K170834.
What company makes CERABIEN ZR?
CERABIEN ZR is manufactured by Kuraray Noritake Dental, Inc..
What is the FDA product code for CERABIEN ZR?
The FDA product code for CERABIEN ZR is EIH.
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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.