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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Rotary Bone Cutting
510(k) Number K932255
Device Name YOUNG D'GRANULATOR
Applicant
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. E.
Earth City,  MO  63045
Applicant Contact JEFF KOPP
Correspondent
Young Dental Manufacturing Co. 1, LLC
13705 Shoreline Ct. E.
Earth City,  MO  63045
Correspondent Contact JEFF KOPP
Regulation Number872.4120
Classification Product Code
KMW  
Date Received05/10/1993
Decision Date 04/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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