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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K030161
Device Name SUPERBOND
Applicant
American Dent-All, Inc.
5140 San Fernando Rd.
Glendale,  CA  91204
Applicant Contact PHILIP HACOPIANS
Correspondent
American Dent-All, Inc.
5140 San Fernando Rd.
Glendale,  CA  91204
Correspondent Contact PHILIP HACOPIANS
Regulation Number872.3710
Classification Product Code
EJH  
Date Received01/16/2003
Decision Date 03/17/2003
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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