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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K100301
Device Name OPAL BOND FLOW
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Applicant Contact DIANE ROGERS
Correspondent
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN,  UT  84095
Correspondent Contact DIANE ROGERS
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/03/2010
Decision Date 04/29/2010
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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