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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K171377
Device Name Young INFINITY Cordless Handpiece System
Applicant
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Cteast
Earth City,  MO  63045
Applicant Contact Brian Prange
Correspondent
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Cteast
Earth City,  MO  63045
Correspondent Contact Brian Prange
Regulation Number872.4200
Classification Product Code
EKX  
Date Received05/10/2017
Decision Date 08/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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