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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sealant, pit and fissure, and conditioner
510(k) Number K190998
Device Name BA Pit & Fissure Sealant
Applicant
Apex Dental Materials, Inc.
330 Telser Road
Lake Zurich,  IL  60047
Applicant Contact Scott Lamerand
Correspondent
Apex Dental Materials, Inc.
330 Telser Road
Lake Zurich,  IL  60047
Correspondent Contact Scott Lamerand
Regulation Number872.3765
Classification Product Code
EBC  
Date Received04/16/2019
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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