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Itena Clinical

France · Paris

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Australia, Israel — 6 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 7Class II 5Class III 0

plus 20 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

8valid device licences

Class I 1Class II 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 1IIa 13

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States20 registration records, 8 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: Itena Clinical Villepinte · ITENA CLINICAL

FDA 510(k) clearances by year

62013 · K122551

22017 · K170207

FDA listed device types

showing 8 of 12

Disk, Abrasive 1Applicator, Resin 1Wheel, Polishing Agent 1Point, Abrasive 1Handle, Instrument, Dental 1Drill, Dental, Intraoral 1Post, Root Canal 1Sealant, Pit And Fissure, And Conditioner 1

Market	Identifier	Name	Class / date
US	K170207	Obturys	2017-07-31
US	K162960	TotalC-Ram	2017-03-14
US	K122551	PROVITEMP	2013-06-14
SA	ME0000001212SFDAA00002	DENTOCLIC FIBER POST	—

Itena Clinical

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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