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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 K850084
Device Name TRINDIUM-DENTAL MATERIAL
Applicant
Trindium Corp. of America
231 Genesee St.
Utica,  NY  13501
Applicant Contact ANTHONY T PANZONE
Correspondent
Trindium Corp. of America
231 Genesee St.
Utica,  NY  13501
Correspondent Contact ANTHONY T PANZONE
Regulation Number872.3710
Classification Product Code
EJH  
Date Received01/10/1985
Decision Date 07/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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