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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 K222044
Device Name Elos Accurate Customized Abutment
Elos Medtech Pinol A/S
Engvej 33
Goerloese,  DK 3330
Applicant Contact Lise Terkelsen
Elos Medtech Pinol A/S
Engvej 33
Goerloese,  DK 3330
Correspondent Contact Lise Terkelsen
Regulation Number872.3630
Classification Product Code
Subsequent Product Code
Date Received07/11/2022
Decision Date 11/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No