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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K191453
Device Name Cervitec F
Applicant
Ivoclar Vivadent, AG
Bendererstrasse 2
Schaan,  LI FL-9494
Applicant Contact Sandra Cakebread
Correspondent
Ivoclar Vivadent, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact Lori Aleshin
Regulation Number872.3260
Classification Product Code
LBH  
Date Received05/31/2019
Decision Date 02/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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