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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K031204
Device Name DENTAPORT ZX
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
EKX  
Subsequent Product Code
LQY  
Date Received04/16/2003
Decision Date 08/21/2003
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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