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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K063236
Device Name BETA-POWDER
Applicant
Brainbase Corporation
Yoneyama 2nd Bldg. 6f
22-13, Oi 1-Chome
Shinagawa-Ku Tokyo,  JP 140-0014
Applicant Contact SATOSHI NOAKE
Correspondent
Brainbase Corporation
Yoneyama 2nd Bldg. 6f
22-13, Oi 1-Chome
Shinagawa-Ku Tokyo,  JP 140-0014
Correspondent Contact SATOSHI NOAKE
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received10/25/2006
Decision Date 02/16/2007
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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