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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 K242025
Device Name Elos Accurate® Hybrid Base™
Applicant
Elos Medtech Pinol A/S
Engvej 33
Goerloese,  DK 3330
Applicant Contact Lise Terkelsen
Correspondent
Elos Medtech Pinol A/S
Engvej 33
Goerloese,  DK 3330
Correspondent Contact Lise Terkelsen
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received07/11/2024
Decision Date 12/10/2024
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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