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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 K061438
Device Name ULTRAEZ DESENSITIZING GEL
Applicant
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Applicant Contact TAMMY LAVERY
Correspondent
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Correspondent Contact TAMMY LAVERY
Regulation Number872.3260
Classification Product Code
LBH  
Date Received05/24/2006
Decision Date 06/12/2007
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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