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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
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