HomeGermanyKettenbach GmbH & Co. KG

Kettenbach GmbH & Co. KG

Germany · Eschenburg
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
12listed device types
Class I 4Class II 8Class III 0
plus 21 registration records and 13 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
8registered devices
Class I 1Class II 7
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
8registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
14 including historic records
TWTaiwanTFDA
8valid device licences
Class I 1Class II 7
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
15active ARTG entries
Class I 8IIa 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 4
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States21 registration records, 13 510(k), 0 PMA
Brazil8 confirmed, 0 excluded
Saudi Arabia8 confirmed, 0 excluded
Manufacturer names merged into this page: KETTENBACH GMBH & CO KG · KETTENBACH GMBH & CO. KG · Kettenbach GmbH & Co. KG · Kettenbach GmbH & Co KG

Company information

Country
Germany
City
Eschenburg

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

32008
22009
12011
12012
12015
32019
12023
12025

FDA listed device types

showing 8 of 12
Syringe, Restorative And Impression Material 1Material, Impression Tray, Resin 1Agent, Polishing, Abrasive, Oral Cavity 1Tray, Impression, Preformed 1Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Material, Tooth Shade, Resin 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250267Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)2025-03-14
USK230333Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)2023-07-24
USK191527Visalys CemCore, Visalys Cem Core Try In Paste2019-11-08
BR80117589163Visalys Temp ONE:ONEClass II
BR80117580507Mucopren SoftClass II
BR80117580503Visalys TempClass II
SAME0000011405SFDAA00020PANASIL®
SAME0000011405SFDAA00019FUTAR®

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