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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K061701
Device Name HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
Applicant
J. Morita USA, Inc.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
J. Morita USA, Inc.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Correspondent Contact KEITH A BARRITT
Regulation Number872.4200
Classification Product Code
EFA  
Date Received06/16/2006
Decision Date 08/25/2006
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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