Manufacturer registered with FDA

Septodont

CEDEX, France. Lists 6 dental device types with FDA across 2 registered establishments, and holds 17 510(k) clearances as applicant.

FDA owner/operator8010102Contract manufacturerForeign exporterManufacturer

Device types listed: 6
Brands and models: 0
510(k) clearances: 171976–2021
Markets registered in: 8125 registrations outside the US
Establishments: 2France, India

510(k) clearances per year, 1976–2026

Registered in 8 markets

Where regulators' registries name Septodont as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: FranceOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Septodont	17 clearances	1976–2021	Below
European Union	EUDAMED	Registration holder	SEPTODONT	72	—	Pure Global AI
India	CDSCO	Registration holder	Septodont Healthcare India Private Limited	23	2019–2025	Pure Global AI
Brazil	ANVISA	Manufacturer	SEPTODONT SASSEPTODONT · SEPTODONT HEALTHCARE INDIA PRIVATE LTDA	9	2015–2026	Pure Global AI
Colombia	INVIMA	Manufacturer	SEPTODONT	9	—	Pure Global AI
Taiwan	TFDA	Manufacturer	SEPTODONT	9	2006–2013	Pure Global AI
Peru	DIGEMID	Manufacturer	SEPTODONT	2	2018–2021	Pure Global AI
Australia	TGA	Manufacturer	Septodont Healthcare India Pvt Ltd	1	2018–2018	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Septodont currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Maker	—	2013
Cartridge SyringeEJI · Class 2	Dental needles & syringes	Maker	—	2010
Dental CementEMA · Class 2	Dental cements	Maker	—	2010
Dental NeedleDZM · Class 1	Dental needles & syringes	Maker	—	1985
Impression MaterialELW · Class 2	Impression materials	Maker	—	2009
Synthetic Bone Grafting MaterialLYC · Class 2	Bone grafts & membranes	Maker	—	2008

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Septodont as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
16 Sep 2021	K212283	BioRoot Flow 0.5g, BioRoot Flow 2g	KIF Root Canal Filling Resin
10 Aug 2021	K211799	Biodentine XP 500, Biodentine XP 200	KIF Root Canal Filling Resin
13 Feb 2018	K172839	ENDOSOLV	KIF Root Canal Filling Resin
27 Jun 2014	K140132	BIODENTINE	KIF Root Canal Filling Resin
30 Oct 2009	K092251	BIODENTINE	KIF Root Canal Filling Resin
11 May 2007	K063634	RTR SYRINGE	LYC Synthetic Bone Grafting Material
2 May 2005	K051010	SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70	EJJ Amalgam Alloy
20 Nov 2003	K032708	PLASTALGIN AND PLASTALGIN ORTHO	ELW Impression Material
30 Jan 2003	K023976	ACROSEAL ROOT CANAL OR APICAL SEALER	KIF Root Canal Filling Resin
4 Jan 1978	K771114	NEUTROCIM	EMA Dental Cement
3 Jan 1977	K761355	SELFAST	EMA Dental Cement
3 Jan 1977	K761354	CIMPAT (PINK AND WHITE)	EMA Dental Cement
19 Nov 1976	K761024	RACESTYPTINE RINGS	EIG All Types Retractor
27 Sep 1976	K760660	HYDROL	LBH Cavity Varnish
27 Sep 1976	K760659	CALCIPULPE	EJK Calcium Hydroxide Cavity Liner
27 Sep 1976	K760658	DETARTRINE P	EJR Oral Cavity Abrasive Polishing Agent
27 Sep 1976	K760657	RACESTYPTINE CORD	EIG All Types Retractor

Also lists devices cleared under other names

Septodont lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Novocol, Inc. (1), Arent Fox (1), North Pacific Dental, Inc. (1).

Decided	510(k)	Device	Applicant	Device type
17 Oct 2013	K130601	BIOROOT RCS	Novocol, Inc.	KIF Root Canal Filling Resin
11 Jul 1995	K945843	SAFETY PLUS	Arent Fox	EJI Cartridge Syringe
1 Mar 1983	K830117	ENDOMET	North Pacific Dental, Inc.	EMA Dental Cement

Registered establishments

Establishment	Location	What it does
SEPTODONTFDA reg. 9610964	CEDEX Val-de-Marne, France	Contract manufacturer, Manufacturer
SEPTODONT HEALTHCARE INDIA PRIVATE LTD.FDA reg. 3004443427	VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra, India	Foreign exporter, Manufacturer

Other names on FDA records

Septodont Healthcare India Private Limited

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010102). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.