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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
Model TRA-200,TRA-200-CP3, TRA-200-CP4
Device Name AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
Original Applicant
1425 k street nw
suite 1100
washington,  DC  20005
Original Contact keith barritt
Regulation Number872.4200
Classification Product Code
Date Received04/14/2009
Decision Date 10/16/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No