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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 K921979
Device Name ROOT ZX
Applicant
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Applicant Contact RONALD D NEWMAN
Correspondent
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Correspondent Contact RONALD D NEWMAN
Classification Product Code
LQY  
Date Received04/28/1992
Decision Date 05/27/1993
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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