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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 K220252
Device Name High Retention Attachment System
Applicant
Zest Anchors, LLC
2875 Loker E.
Carlsbad,  CA  92026
Applicant Contact Richard Hines
Correspondent
Zest Anchors, LLC
2875 Loker E.
Carlsbad,  CA  92026
Correspondent Contact Richard Hines
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/31/2022
Decision Date 04/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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