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510(k) K193301

coDiagnostiX by Dental Wings GmbH — Product Code DZJ

K193301 is an FDA 510(k) premarket notification submitted by Dental Wings GmbH for the device "coDiagnostiX". The FDA issued a decision of Substantially Equivalent on June 21, 2021. The device falls under product code DZJ (Driver, Wire, And Bone Drill, Manual), a Class II device regulated under 21 CFR 872.4120.

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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FDA data resources