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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K022147
Device Name DENTA PORT
Applicant
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
J. Morita USA, Inc.
601 13th St. NW
Suite 500 N.
Washington,  DC  20005
Correspondent Contact KEITH A BARRITT
Classification Product Code
LQY  
Subsequent Product Code
EKX  
Date Received07/02/2002
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
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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