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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 K132109
Device Name ENAMELAST
Applicant
ULTRADENT PRODUCTS INC. / ORATECH LLC
810 N 2200 W
Salt Lake City,  UT  84116
Applicant Contact KAREN KAKUNES
Correspondent
ULTRADENT PRODUCTS INC. / ORATECH LLC
810 N 2200 W
Salt Lake City,  UT  84116
Correspondent Contact KAREN KAKUNES
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/08/2013
Decision Date 11/01/2013
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
Recalls CDRH Recalls
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