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Septodont, Inc.

France · Saint Maur Des Fosses Cedex

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 8 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 2Class II 4Class III 0unclassified 1

plus 13 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

7active device licences

Class II 4Class III 3

19 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 2CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

11active ARTG entries

Class I 4Class III 3IIa 3Class Is (sterile) 1

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 States13 registration records, 20 510(k), 0 PMA, 4 excluded

Brazil4 confirmed, 1 excluded

Canada7 confirmed, 2 excluded

Manufacturer names merged into this page: SEPTODONT · Septodont, Inc · SEPTODONT SAS

FDA 510(k) clearances by year

71976

21977

21978

12003

12005

12007

12009

12010

12014

12018

22021

FDA listed device types

Resin, Root Canal Filling 1Bone Grafting Material, Synthetic 1Syringe, Cartridge 1Cement, Dental 1Needle, Dental 1Instrument, Filling, Plastic, Dental 1Cord, Retraction 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212283	BioRoot Flow 0.5g, BioRoot Flow 2g	2021-09-16
US	K211799	Biodentine XP 500, Biodentine XP 200	2021-08-10
US	K172839	ENDOSOLV	2018-02-13
BR	10291220080	SEPTOJECT XL	Class I
BR	10291229006	septoject xl	Class II
BR	10291220087	CIMPAT	Class II
CA	19579	KIT PARCAN	Class II
CA	20333	PROVISCELL	Class II
CA	87487	ACROSEAL	Class III

Septodont, Inc.

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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