Faico Dental Implant System

Implant, Endosseous, Root-form

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.

Pre-market Notification Details

Device IDK192015
510k NumberK192015
Device Name:Faico Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant FAICO Medical LLC 9689 Parkview Ave Boca Raton,  FL  33428
ContactHernan Dario Fernandez
CorrespondentRaymond Kelly
Licensale Inc 3422 Leonard Ln New Smyrna Beach,  FL  32168
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-29
Decision Date2020-04-03

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