ENA HFO COMPOSITE SYSTEM

Material, Tooth Shade, Resin

MICERIUM S.P.A.

The following data is part of a premarket notification filed by Micerium S.p.a. with the FDA for Ena Hfo Composite System.

Pre-market Notification Details

Device IDK062906
510k NumberK062906
Device Name:ENA HFO COMPOSITE SYSTEM
ClassificationMaterial, Tooth Shade, Resin
Applicant MICERIUM S.P.A. VIA MARCONI 83 Avengo,  IT 16030
ContactEugenio Miceli
CorrespondentEugenio Miceli
MICERIUM S.P.A. VIA MARCONI 83 Avengo,  IT 16030
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-27
Decision Date2006-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EMICEHF5N1 K062906 000
EMICEHR4F0 K062906 000
EMICEHR4F1 K062906 000
EMICEHR4FC0 K062906 000
EMICEHR4FC1 K062906 000
EMICEHR6B0 K062906 000
EMICEHR6B1 K062906 000
EMICEHR6FC0 K062906 000
EMICEHR6FC1 K062906 000
EMICEHRBD00 K062906 000
EMICEHRBD01 K062906 000
EMICEHRBD050 K062906 000
EMICEHRBD051 K062906 000
EMICEHRBD10 K062906 000
EMICEHR3FC1 K062906 000
EMICEHR3FC0 K062906 000
EMICEHR151 K062906 000
EMICEHF6N0 K062906 000
EMICEHF6N1 K062906 000
EMICEHF7N0 K062906 000
EMICEHF7N1 K062906 000
EMICEHF8N0 K062906 000
EMICEHF8N1 K062906 000
EMICEHFS0 K062906 000
EMICEHFS1 K062906 000
EMICEHOA0 K062906 000
EMICEHOA1 K062906 000
EMICEHOBN0 K062906 000
EMICEHOBN1 K062906 000
EMICEHR150 K062906 000
EMICEHRBD11 K062906 000
EMICEHRBD20 K062906 000
EMICEHRBD21 K062906 000
EMICEHRBF31 K062906 000
EMICEHREF10 K062906 000
EMICEHREF11 K062906 000
EMICEHREF20 K062906 000
EMICEHREF21 K062906 000
EMICEHREF30 K062906 000
EMICEHREF31 K062906 000
EMICEHRFUD00 K062906 000
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EMICEHRFUD050 K062906 000
EMICEHRFUD051 K062906 000
EMICEHRFUD10 K062906 000
EMICEHRFUD11 K062906 000
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EMICEHRBF2F1 K062906 000
EMICEHRBF21 K062906 000
EMICEHRBD30 K062906 000
EMICEHRBD31 K062906 000
EMICEHRBD350 K062906 000
EMICEHRBD351 K062906 000
EMICEHRBD40 K062906 000
EMICEHRBD41 K062906 000
EMICEHRBD50 K062906 000
EMICEHRBD51 K062906 000
EMICEHRBD60 K062906 000
EMICEHRBD61 K062906 000
EMICEHRBF10 K062906 000
EMICEHRBF11 K062906 000
EMICEHRBF20 K062906 000
EMICEHRFUD20 K062906 000
EMICETOD1 K062906 000
EMICEHTSF10 K062906 000
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EMICEHR6T0 K062906 000
EMICEHFB30 K062906 000
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EMICEHFB40 K062906 000
EMICEHFB41 K062906 000
EMICEHFUD10 K062906 000
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EMICEHFUD20 K062906 000
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EMICEHFUD30 K062906 000
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EMICEHTSF1 K062906 000
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EMICETOL1 K062906 000
EMICETOP1 K062906 000
EMICETPD1 K062906 000
EMICETPL1 K062906 000
EMICETPT0 K062906 000
EMICETPT1 K062906 000
EMICETSVN0 K062906 000
EMICETSVN1 K062906 000
EMICEH5UB0 K062906 000
EMICEHFGC0 K062906 000
EMICEHFGC1 K062906 000
EMICEHR5UB1 K062906 000
EMICEHTS20 K062906 000
EMICEHFUD350 K062906 000
EMICEHFUD351 K062906 000
EMICEHFUD40 K062906 000
EMICEFFUD51 K062906 000
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EMICEH2OA0 K062906 000
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EMICEH2OBN1 K062906 000
EMICEHF1N0 K062906 000
EMICEHF1N1 K062906 000
EMICEHF3N0 K062906 000
EMICEHF3N1 K062906 000
EMICEHF4N0 K062906 000
EMICEHF4N1 K062906 000
EMICEFFUD50 K062906 000
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EMICEHFUD50 K062906 000
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EMICEHR3FB1 K062906 000
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EMICEFFUD30 K062906 000
EMICEFFUD31 K062906 000
EMICEFFUD350 K062906 000
EMICEFFUD351 K062906 000
EMICEHF5N0 K062906 000
EMICEHRUD60 K062906 000
EMICERBD10 K062906 000
EMICERBD20 K062906 000
EMICERBD30 K062906 000
EMICERBD40 K062906 000
EMICERBF10 K062906 000
EMICERBF11 K062906 000
EMICERBF20 K062906 000
EMICERBF21 K062906 000
EMICERBF30 K062906 000
EMICERBF31 K062906 000
EMICEREF10 K062906 000
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EMICEREF20 K062906 000
EMICER3FC1 K062906 000
EMICER3FC0 K062906 000
EMICER3FB1 K062906 000
EMICEHRUD61 K062906 000
EMICEHRUE10 K062906 000
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EMICEHRUE20 K062906 000
EMICEHRUE21 K062906 000
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EMICEHRUE31 K062906 000
EMICEHTOA1 K062906 000
EMICEHTOBN1 K062906 000
EMICEHTUD31 K062906 000
EMICER3E0 K062906 000
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EMICEREF21 K062906 000
EMICEREF30 K062906 000
EMICEREF31 K062906 000
EMICERUD40 K062906 000
EMICERUD41 K062906 000
EMICERUD50 K062906 000
EMICERUD51 K062906 000
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EMICERUE11 K062906 000
EMICERUE20 K062906 000
EMICERUE21 K062906 000
EMICERUE30 K062906 000
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EMICETPKIT0 K062906 000
EMICETPKIT1 K062906 000
EMICETST0 K062906 000
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EMICERUD350 K062906 000
EMICERUD31 K062906 000
EMICERIW0 K062906 000
EMICERIW1 K062906 000
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EMICERIWS1 K062906 000
EMICERUD00 K062906 000
EMICERUD01 K062906 000
EMICERUD050 K062906 000
EMICERUD051 K062906 000
EMICERUD10 K062906 000
EMICERUD11 K062906 000
EMICERUD20 K062906 000
EMICERUD21 K062906 000
EMICERUD30 K062906 000
EMICETST1 K062906 000
EMICEHRFUD21 K062906 000
EMICEHRTBD01 K062906 000
EMICEHRTBD051 K062906 000
EMICEHRTBD11 K062906 000
EMICEHRTBD21 K062906 000
EMICEHRTBD31 K062906 000
EMICEHRTBD351 K062906 000
EMICEHRTBD41 K062906 000
EMICEHRTBD51 K062906 000
EMICEHRTBD61 K062906 000
EMICEHRTBF11 K062906 000
EMICEHRTBF21 K062906 000
EMICEHRTBF31 K062906 000
EMICEHRTEF11 K062906 000
EMICEHRIWS1 K062906 000
EMICEHRIWS0 K062906 000
EMICEHRIW1 K062906 000
EMICEHRFUD30 K062906 000
EMICEHRFUD31 K062906 000
EMICEHRFUD350 K062906 000
EMICEHRFUD351 K062906 000
EMICEHRFUD40 K062906 000
EMICEHRFUD41 K062906 000
EMICEHRFUD50 K062906 000
EMICEHRFUD51 K062906 000
EMICEHRFUD60 K062906 000
EMICEHRFUD61 K062906 000
EMICEHRIM0 K062906 000
EMICEHRIM1 K062906 000
EMICEHRIW0 K062906 000
EMICEHRTEF21 K062906 000
EMICEHRTEF31 K062906 000
EMICEHRTIM1 K062906 000
EMICEHRUD050 K062906 000
EMICEHRUD051 K062906 000
EMICEHRUD10 K062906 000
EMICEHRUD11 K062906 000
EMICEHRUD20 K062906 000
EMICEHRUD21 K062906 000
EMICEHRUD30 K062906 000
EMICEHRUD31 K062906 000
EMICEHRUD350 K062906 000
EMICEHRUD351 K062906 000
EMICEHRUD40 K062906 000
EMICEHRUD41 K062906 000
EMICEHRUD50 K062906 000
EMICEHRUD01 K062906 000
EMICEHRUD00 K062906 000
EMICEHRTUE31 K062906 000
EMICEHRTIW1 K062906 000
EMICEHRTIWS1 K062906 000
EMICEHRTUD01 K062906 000
EMICEHRTUD051 K062906 000
EMICEHRTUD11 K062906 000
EMICEHRTUD21 K062906 000
EMICEHRTUD31 K062906 000
EMICEHRTUD351 K062906 000
EMICEHRTUD41 K062906 000
EMICEHRTUD51 K062906 000
EMICEHRTUD61 K062906 000
EMICEHRTUE11 K062906 000
EMICEHRTUE21 K062906 000
EMICEHRUD51 K062906 000
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