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FKG DENTAIRE SARL

Switzerland · Le Cret-Du-Locle

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 9 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

9listed device types

Class I 9Class II 0Class III 0

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 6Class II 4

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

22active ARTG entries

Class I 8IIa 12Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States9 registration records, 0 510(k), 0 PMA

Brazil10 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: FKG DENTAIRE SARL · FKG DENTAIRE SÀRL · FKG Dentaire SA

FDA listed device types

showing 8 of 9

Spreader, Pulp Canal Filling Material, Endodontic 1Instruments, Dental Hand 1Plugger, Root Canal, Endodontic 1Reamer, Pulp Canal, Endodontic 1Instrument, Filling, Plastic, Dental 1Broach, Endodontic 1File, Pulp Canal, Endodontic 1Drill, Dental, Intraoral 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10258190096	INSTRUMENTOS PARA PREPARO DE CANAL EM AÇO COM CABO FKG	Class I
BR	10258190129	INSTRUMENTO PARA PREPARO DE CANAL SEM CABO FKG	Class II
BR	10258190166	INSTRUMENTOS ROTATÓRIOS FKG	Class II
SA	ME0000009576SFDAA00001	H Files	—
SA	ME0000009576SFDAA00002	K Files	—

FKG DENTAIRE SARL

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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