MTA FILLAPEX

Resin, Root Canal Filling

ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA

The following data is part of a premarket notification filed by Angelus Industria De Productos Odontologicos Sa with the FDA for Mta Fillapex.

Pre-market Notification Details

Device IDK140247
510k NumberK140247
Device Name:MTA FILLAPEX
ClassificationResin, Root Canal Filling
Applicant ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA 18851 NE 29TH AVE 720 Aventura,  FL  33180
ContactTara Conrad
CorrespondentTara Conrad
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA 18851 NE 29TH AVE 720 Aventura,  FL  33180
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-30
Decision Date2014-04-25
Summary:summary

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