GRANDIO SO FLOW

Material, Tooth Shade, Resin

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio So Flow.

Pre-market Notification Details

Device IDK103580
510k NumberK103580
Device Name:GRANDIO SO FLOW
ClassificationMaterial, Tooth Shade, Resin
Applicant VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven,  DE D-27472
ContactManfred Thomas Plaumann
CorrespondentManfred Thomas 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 Received2010-12-06
Decision Date2011-01-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22127491 K103580 000
E22127231 K103580 000
E22127241 K103580 000
E22127251 K103580 000
E22127261 K103580 000
E22127271 K103580 000
E22127291 K103580 000
E22127301 K103580 000
E22127321 K103580 000
E22127331 K103580 000
E22127341 K103580 000
E22127361 K103580 000
E22127371 K103580 000
E22127421 K103580 000
E22127431 K103580 000
E22127441 K103580 000
E22127451 K103580 000
E22127461 K103580 000
E22127221 K103580 000

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