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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 K193496
Device Name CharmFil
Applicant
Dentkist, Inc.
3, Nongshim-Ro
Gunpo-Si,  KR 15842
Applicant Contact Shin Haeng Lee
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/17/2019
Decision Date 05/06/2020
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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