KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B

Crown And Bridge, Temporary, Resin

KETTENBACH GMBH & CO KG

The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Kingscross Pl-c+b-10, Kingscross Pl-c+b-12, Kingscross Pl-c+b-08, Kingscross B.

Pre-market Notification Details

Device IDK122039
510k NumberK122039
Device Name:KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
ClassificationCrown And Bridge, Temporary, Resin
Applicant KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg,  DE 35713
ContactJuergen Berger
CorrespondentJuergen Berger
KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg,  DE 35713
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-11
Decision Date2012-12-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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E217137951 K122039 000
E217137941 K122039 000
E21713790US1 K122039 000
E21713788US1 K122039 000
E217137851 K122039 000
E21713784US1 K122039 000
E217137831 K122039 000
E21713782US1 K122039 000
E217137821 K122039 000
E21713781US1 K122039 000
E217137811 K122039 000
E21713780US1 K122039 000
E217137981 K122039 000
D813CR12180 K122039 000
D813CR12190 K122039 000
00883205107893 K122039 000
00883205107886 K122039 000
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00883205107862 K122039 000
00883205107855 K122039 000
66714700000159 K122039 000
D813SPD13090 K122039 000
D813SPD13080 K122039 000
D813SPD13070 K122039 000
D813SPD13060 K122039 000
D813SPD13050 K122039 000
D813CR12200 K122039 000
E217137801 K122039 000

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