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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 K192457
Device Name Elos Accurate Customized Abutment
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  
Date Received09/09/2019
Decision Date 01/02/2020
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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