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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K010547
Device Name VERTEX SEALAND L/C ORTHODONTIC SEALANT
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 Number872.3200
Classification Product Code
KLE  
Date Received02/23/2001
Decision Date 08/16/2001
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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