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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 Drive
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
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