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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 K213391
Device Name High Retention Attachment System
Applicant
Zest Anchors, LLC
2875 Loker Avenue East
Carlsbad,  CA  92010
Applicant Contact Mark Stavro
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Melissa Burbage
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/15/2021
Decision Date 01/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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