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FDA 510(k) Application Details - K193301
Device Classification Name
Driver, Wire, And Bone Drill, Manual
More FDA Info for this Device
510(K) Number
K193301
Device Name
Driver, Wire, And Bone Drill, Manual
Applicant
Dental Wings GmbH
Duesseldorfer Platz 1
Chemnitz 09111 DE
Other 510(k) Applications for this Company
Contact
Angelika HΣhnel
Other 510(k) Applications for this Contact
Regulation Number
872.4120
More FDA Info for this Regulation Number
Classification Product Code
DZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/29/2019
Decision Date
06/21/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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