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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 K201860
Device Name Elos Accurate Hybrid Base
Applicant
Elos Medtech Pinol A/S
Engvej 33
Goerloese,  DK dk-3330
Applicant Contact Tina Friis Poulsen
Correspondent
Elos Medtech Pinol A/S
Engvej 33
Goerloese,  DK dk-3330
Correspondent Contact Tina Friis Poulsen
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received07/06/2020
Decision Date 02/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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