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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K013869
Device Name SR IVOCRON
Applicant
Ivoclar Vivadent, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact DONNA M HARTNETT
Correspondent
Ivoclar Vivadent, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact DONNA M HARTNETT
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
EBF  
Date Received11/21/2001
Decision Date 08/28/2002
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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