HomeGermanyDental Direkt GmbH

Dental Direkt GmbH

Germany · Spenge
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 7 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
7listed device types
Class I 1Class II 5Class III 0unclassified 1
plus 14 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
1active device licences
Class II 1
6 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
IIa 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
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 States14 registration records, 11 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: Dental Direkt GmbH · DENTAL DIREKT GMBH

Company information

Country
Germany
City
Spenge

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

12010
22015
12016
12017
12019
12020
32023
12024

FDA listed device types

Resin, Denture, Relining, Repairing, Rebasing 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Abutment, Implant, Dental, Endosseous 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1Mouthguard, Prescription 1Accessories, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241579DD Hybridlayer (multicolored zirconia)2024-09-06
USK230410DD medical polymers (PMMA)2023-06-23
USK230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)2023-04-25
BR80662060003Família de cerâmicas odontológicas processadas por usinagemClass II
BR80662060004Cerâmica odontológica dd nature zrClass II
CA105035DD BIO SPLINT CClass II

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