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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K212283
Device Name BioRoot Flow 0.5g, BioRoot Flow 2g
Applicant
Septodont
58, Rue Du Pont De Creteil
Saint-Maur Des Fosses Cedex,  FR 94107
Applicant Contact Kimty Bui Van
Correspondent
Septodont
205 Granite Run Dr., Suite 150
Lancaster,  PA  17601
Correspondent Contact Greg Montgomery
Regulation Number872.3820
Classification Product Code
KIF  
Date Received07/21/2021
Decision Date 09/16/2021
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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