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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 K231307
Device Name Elos Accurate Customized Abutment
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 Received05/05/2023
Decision Date 12/21/2023
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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