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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K012877
Device Name HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
Applicant
Ivoclar USA, Inc.
175 Pineview Dr.
Amherst,  NY  14150
Applicant Contact ANDERJEET GULATI
Correspondent
Ivoclar USA, Inc.
175 Pineview Dr.
Amherst,  NY  14150
Correspondent Contact ANDERJEET GULATI
Regulation Number872.3060
Classification Product Code
EJT  
Date Received08/27/2001
Decision Date 11/21/2001
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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