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FDA 510(k) Application Details - K171377
Device Classification Name
Handpiece, Direct Drive, Ac-Powered
More FDA Info for this Device
510(K) Number
K171377
Device Name
Handpiece, Direct Drive, Ac-Powered
Applicant
Young Dental Manufacturing Co 1, LLC
13705 Shoreline CtEast
Earth City, MO 63045 US
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Contact
Brian Prange
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/10/2017
Decision Date
08/20/2018
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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