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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 K091065
Device Name AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
Applicant
J. MORITA USA, INC.
1425 K STREET NW
SUITE 1100
WASHINGTON,  DC  20005
Applicant Contact KEITH BARRITT
Correspondent
J. MORITA USA, INC.
1425 K STREET NW
SUITE 1100
WASHINGTON,  DC  20005
Correspondent Contact KEITH BARRITT
Regulation Number872.4200
Classification Product Code
EFB  
Date Received04/14/2009
Decision Date 10/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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