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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 K191919
Device Name Elos Accurate Hybrid Base
Applicant
Elos Medtech Pinol A/S
Engvej 33
gorlose,  DK dk-3330
Applicant Contact tina friis poulsen
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact floyd g. larson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/18/2019
Decision Date 02/10/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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