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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K123215
FOIA Releasable 510(k) K123215
Device Name VISCOSTAT CLEAR
Applicant
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Applicant Contact KAREN KAKUNES
Correspondent
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Correspondent Contact KAREN KAKUNES
Classification Product Code
MVL  
Date Received10/15/2012
Decision Date 02/05/2013
Decision Substantially Equivalent (SESE)
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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