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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 K190271
Device Name FiteBac Cavity Cleanser
Applicant
Largent Health, LLC
3698 Largent Way NW, Suite 101
Marietta,  GA  30064
Applicant Contact Kirk Kimmerling
Correspondent
Securebiomed Evaluations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact Elizabeth O'Keeffe
Regulation Number872.3260
Classification Product Code
LBH  
Date Received02/08/2019
Decision Date 01/23/2020
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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