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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 K200355
Device Name Duranext Abutments
Applicant
Elegant Dental Corp.
2308 McDonald Avenue
Brooklyn,  NY  11223
Applicant Contact Gary Fingerman
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Floyd G Larson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/13/2020
Decision Date 07/22/2020
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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