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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K231263
Device Name Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT
Applicant
Prevest Denpro Limited
Unit Ii, Export Promotion Industrial Park
Bari Brahmana,  IN 181133
Applicant Contact Atul Modi
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,,  OR  97030 -0172
Correspondent Contact Angela Blackwell
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/02/2023
Decision Date 01/05/2024
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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