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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 K030436
Device Name BIO UNIVERSAL
Applicant
IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST,  NY  14228
Applicant Contact ANDERJEET GULATI
Correspondent
IVOCLAR VIVADENT, INC.
175 PINEVIEW DR.
AMHERST,  NY  14228
Correspondent Contact ANDERJEET GULATI
Regulation Number872.3060
Classification Product Code
EJT  
Date Received02/10/2003
Decision Date 04/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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