DSP Implant System

Implant, Endosseous, Root-form

D.S.P Industrial Eireli

The following data is part of a premarket notification filed by D.s.p Industrial Eireli with the FDA for Dsp Implant System.

Pre-market Notification Details

Device IDK192839
510k NumberK192839
Device Name:DSP Implant System
ClassificationImplant, Endosseous, Root-form
Applicant D.S.P Industrial Eireli Rua Marechal Floriano Peixoto 303 - Ouro Verde II Campo Largo,  BR 83606-290
ContactCelio Gilson Netzel
CorrespondentGraziela Brum
PR Servicos Regulatorios Administrarivos Ltda Rua Alice Alem Saadi, 855/2404 Ribeirao Preto,  BR 14096-770
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2021-02-11

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