KETTOSIL AND SILGINAT

Material, Impression

KETTENBACH GMBH & CO KG

The following data is part of a premarket notification filed by Kettenbach Gmbh & Co Kg with the FDA for Kettosil And Silginat.

Pre-market Notification Details

Device IDK082157
510k NumberK082157
Device Name:KETTOSIL AND SILGINAT
ClassificationMaterial, Impression
Applicant KETTENBACH GMBH & CO KG IM HEERFELD 7 Eschenburg,  DE 35713
ContactMichaela Zinke
CorrespondentStefan Preiss
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-07-31
Decision Date2008-08-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E217147151 K082157 000
00883205033697 K082157 000
00883205033703 K082157 000
00883205033710 K082157 000
E21713826111 K082157 000
E21713827111 K082157 000
E21713846111 K082157 000
E21713847111 K082157 000
E217138261 K082157 000
E217138271 K082157 000
E217138461 K082157 000
E217138471 K082157 000
E217138481 K082157 000
E217147121 K082157 000
E217147131 K082157 000
E217147141 K082157 000
00883205109019 K082157 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.