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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 K010544
Device Name VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
Applicant
Apex Dental Materials, Inc.
603 Berkley Ct.
Schaumburg,  IL  60194
Applicant Contact SCOTT LAMERAND
Correspondent
Apex Dental Materials, Inc.
603 Berkley Ct.
Schaumburg,  IL  60194
Correspondent Contact SCOTT LAMERAND
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/23/2001
Decision Date 08/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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