FUSION SINGLE LINK

Agent, Tooth Bonding, Resin

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 Fusion Single Link.

Pre-market Notification Details

Device IDK132923
510k NumberK132923
Device Name:FUSION SINGLE LINK
ClassificationAgent, Tooth Bonding, Resin
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 CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-18
Decision Date2014-01-03
Summary:summary

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