N-HYBRIDE-COMPOSITE LC

Material, Tooth Shade, Resin

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for N-hybride-composite Lc.

Pre-market Notification Details

Device IDK113563
510k NumberK113563
Device Name:N-HYBRIDE-COMPOSITE LC
ClassificationMaterial, Tooth Shade, Resin
Applicant VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
ContactM.th. Plaumann
CorrespondentM.th. Plaumann
VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-21
Decision Date2011-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D6620704115610 K113563 000
D66207041147017 K113563 000
D66207041146218 K113563 000
D66207041145419 K113563 000
D6620704114471 K113563 000
D6620704114391 K113563 000

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