HomeIsraelCortex Dental Implants Industries , Ltd.

Cortex Dental Implants Industries , Ltd.

Israel · Shlomi Northern
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, Australia, Israel, Russia — 5 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
5listed device types
Class I 2Class II 3Class III 0
plus 7 registration records and 4 510(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
0active device licences
TWTaiwanTFDA
7valid device licences
Class I 3Class III 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
7active ARTG entries
Class I 2IIa 3IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 1Class 2b 2
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 States7 registration records, 4 510(k), 0 PMA, 10 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: CORTEX DENTAL IMPLANTS INDUSTRIES LTD.

Company information

Country
Israel
City
Shlomi Northern

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

12009 · K090709
12014 · K131258
12017 · K163385
12019 · K181580

FDA listed device types

Drill, Dental, Intraoral 1Accessories, Implant, Dental, Endosseous 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK181580Cortex CAD/CAM Abutments2019-01-29
USK163385Cortex Dental Implant System2017-08-29
USK131258SATURN DENTAL IMPLANT2014-03-17

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