HomeGermanyWieland Dental + Technik GmbH & Co. KG

Wieland Dental + Technik GmbH & Co. KG

Germany · Pforzheim
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Russia — 3 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
45510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 45 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
16active device licences
Class III 16
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States0 registration records, 45 510(k), 0 PMA, 2 excluded
Canada16 confirmed, 0 excluded
Manufacturer names merged into this page: WIELAND DENTAL + TECHNIK GMBH & CO. KG

Company information

Country
Germany
City
Pforzheim

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

242002
42003
32004
32005
22007
22008
32011
12013
32015

Registration details (sample)

MarketIdentifierNameClass / date
USK152118Zenostar MT, Zenostar Color Liquids2015-12-16
USK151142IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID2015-08-13
USK142233zenostar MO, Zenostar T, Zenostar VisualiZr2015-01-05
CA67664DENTAL ALLOYClass III
CA67737REFLEXClass III
CA70168AGC ELECTROFORMING SYSTEMClass III

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