FAICO Dental Implant System And CAD/CAM Abutments

Abutment, Implant, Dental, Endosseous

Faico Medical LLC

The following data is part of a premarket notification filed by Faico Medical Llc with the FDA for Faico Dental Implant System And Cad/cam Abutments.

Pre-market Notification Details

Device IDK211871
510k NumberK211871
Device Name:FAICO Dental Implant System And CAD/CAM Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Faico Medical LLC 2424 North Federal Highway, Suite 103 Boca Raton,  FL  33428
ContactHernan Dario Fernandez
CorrespondentRaymond Kelly
Arazy Group 3422 Leonardo Lane New Smyrna Beach,  FL  32168
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-17
Decision Date2021-11-18

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