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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amalgamator, Dental, Ac-Powered
510(k) Number K901909
Device Name SILAMAT (AMALGAMATOR)
Applicant
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact L SEVERANCE,DDS
Correspondent
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact L SEVERANCE,DDS
Regulation Number872.3100
Classification Product Code
EFD  
Date Received04/27/1990
Decision Date 06/22/1990
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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