DIOnavi-Denture02
K-Number: K210828 · 2021-03-23
ApplicantDio Corporation
Decision Date2021-03-23
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DIOnavi-Denture02 is a medical device manufactured by Dio Corporation. It received FDA 510(k) clearance on 2021-03-23 under approval number K210828. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DIOnavi-Denture02?
DIOnavi-Denture02 is a medical device that received FDA 510(k) clearance on 2021-03-23. It is manufactured by Dio Corporation. The 510(k) number is K210828.
When was DIOnavi-Denture02 approved by the FDA?
DIOnavi-Denture02 received FDA 510(k) clearance on 2021-03-23, under approval number K210828.
What company makes DIOnavi-Denture02?
DIOnavi-Denture02 is manufactured by Dio Corporation.
What is the FDA product code for DIOnavi-Denture02?
The FDA product code for DIOnavi-Denture02 is EBI.
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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.