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510(k) K193301

coDiagnostiX by Dental Wings GmbH — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2021
Date Received
November 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Driver, Wire, And Bone Drill, Manual
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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