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510(k) K210828

DIOnavi-Denture02 by Dio Corporation — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2021
Date Received
March 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

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