S.I.N. Dental Implant System

Implant, Endosseous, Root-form

S.I.N. -Sistema De Implante Nacional S.A.

The following data is part of a premarket notification filed by S.i.n. -sistema De Implante Nacional S.a. with the FDA for S.i.n. Dental Implant System.

Pre-market Notification Details

Device IDK193096
510k NumberK193096
Device Name:S.I.N. Dental Implant System
ClassificationImplant, Endosseous, Root-form
Applicant S.I.N. -Sistema De Implante Nacional S.A. Avenida Vereador Abel Ferreira, 1100 Sao Paulo,  BR 03340-000
ContactDenise Domiciano
CorrespondentKevin A. Thomas
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-07
Decision Date2020-05-14

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