CERABIEN MiLai
K-Number: K250673 · 2025-05-29
ApplicantKuraray Noritake Dental, Inc.
Decision Date2025-05-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CERABIEN MiLai is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2025-05-29 under approval number K250673. 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 MiLai?
CERABIEN MiLai is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K250673.
When was CERABIEN MiLai approved by the FDA?
CERABIEN MiLai received FDA 510(k) clearance on 2025-05-29, under approval number K250673.
What company makes CERABIEN MiLai?
CERABIEN MiLai is manufactured by Kuraray Noritake Dental, Inc..
What is the FDA product code for CERABIEN MiLai?
The FDA product code for CERABIEN MiLai 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.