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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name handpiece, air-powered, dental
510(k) Number K113222
Device Name ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
Original Applicant
NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
59-2 minami-cho
itabashi-ku, tokyo,  JP 173-0027
Original Contact shinichi nakamura
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received11/01/2011
Decision Date 02/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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