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510(k) K181110

PROPHYflex 4 by Kaltenbach & Voigt GmbH — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2019
Date Received
April 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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