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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 K211871
Device Name FAICO Dental Implant System and CAD/CAM Abutments
Applicant
Faico Medical, LLC
2424 N. Federal Highway, Suite 103
Boca Raton,  FL  33428
Applicant Contact Hernan Dario Fernandez
Correspondent
Arazy Group
3422 Leonardo Lane
New Smyrna,  FL  32168
Correspondent Contact Raymond Kelly
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/17/2021
Decision Date 11/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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