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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
Applicant
Nakamura Dental Handpiece Mfg. Co., Ltd.
59-2 Minami-Cho
Itabashi-Ku, Tokyo,  JP 173-0027
Applicant Contact SHINICHI NAKAMURA
Correspondent
Nakamura Dental Handpiece Mfg. Co., Ltd.
59-2 Minami-Cho
Itabashi-Ku, Tokyo,  JP 173-0027
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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