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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K020452
Device Name HIGH SILVER CONVENTIONAL
Applicant
Ab Ardent
54 Riverview Ave.
Tonawanda,  NY  14150
Applicant Contact CLYDE E INGERSOLL
Correspondent
Ab Ardent
54 Riverview Ave.
Tonawanda,  NY  14150
Correspondent Contact CLYDE E INGERSOLL
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received02/11/2002
Decision Date 05/07/2002
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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