DIOnavi-Denture
K-Number: K193623 · 2020-10-22
ApplicantDio Corporation
Decision Date2020-10-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DIOnavi-Denture is a medical device manufactured by Dio Corporation. It received FDA 510(k) clearance on 2020-10-22 under approval number K193623. 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-Denture?
DIOnavi-Denture is a medical device that received FDA 510(k) clearance on 2020-10-22. It is manufactured by Dio Corporation. The 510(k) number is K193623.
When was DIOnavi-Denture approved by the FDA?
DIOnavi-Denture received FDA 510(k) clearance on 2020-10-22, under approval number K193623.
What company makes DIOnavi-Denture?
DIOnavi-Denture is manufactured by Dio Corporation.
What is the FDA product code for DIOnavi-Denture?
The FDA product code for DIOnavi-Denture 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.