TWINKY STAR

Material, Tooth Shade, Resin

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Twinky Star.

Pre-market Notification Details

Device IDK022797
510k NumberK022797
Device Name:TWINKY STAR
ClassificationMaterial, Tooth Shade, Resin
Applicant VOCO GMBH 19379 BLUE LAKE LOOP Bend,  OR  97702
ContactGerald W Shipps
CorrespondentGerald W Shipps
VOCO GMBH 19379 BLUE LAKE LOOP Bend,  OR  97702
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-08-23
Decision Date2002-10-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E22117191 K022797 000
E22116811 K022797 000
E22116821 K022797 000
E22116831 K022797 000
E22116841 K022797 000
E22116851 K022797 000
E22116861 K022797 000
E22116871 K022797 000
E22116881 K022797 000
E22117121 K022797 000
E22117131 K022797 000
E22117141 K022797 000
E22117151 K022797 000
E22117161 K022797 000
E22117171 K022797 000
E22117181 K022797 000
E22116801 K022797 000

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