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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K042056
Device Name AZ ULTRASONIC SYSTEM
Applicant
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Applicant Contact HOWARD ROWE
Correspondent
J. Morita USA, Inc.
9 Mason
Irvine,  CA  92618
Correspondent Contact HOWARD ROWE
Regulation Number872.4850
Classification Product Code
ELC  
Date Received07/30/2004
Decision Date 09/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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