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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K150164
Device Name Monobond Etch & Prime
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 DONNA MARIE HARTNETT
Regulation Number872.3200
Classification Product Code
KLE  
Date Received01/26/2015
Decision Date 04/03/2015
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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