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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K182246
Device Name MIST IC
Applicant
Imagine Milling Technologies, LLC
14225-E Sullyfield Circle
Chantilly,  VA  20151
Applicant Contact Felix Chung
Correspondent
Paxmed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin A. Thomas
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/20/2018
Decision Date 04/16/2019
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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