Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610964

FEI Number

1000477999

Entity Name

SEPTODONT

City/State/Country

CEDEX Val-de-Marne, FR

Establishment Address

58, RUE DU PONT DE CRETEIL, SAINT MAUR DES FOSSES, CEDEX Val-de-Marne 94107, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SEPTODONT (Owner Number: 8010102)

Owner / Operator Contact Address

58, RUE DU PONT DE CRETEIL, SAINT MAUR DES FOSSES, CEDEX, FR-NOTA 94107, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2014-10-31
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2014-10-31
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2013-11-13
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-12-03
MVL	Cord, Retraction	Unknown	Class U	N/A	2010-02-19
DZM	Needle, Dental	Dental	Class 1	872.4730	1985-09-30
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-12-07
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2008-03-19
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2018-10-03

Official Correspondent

No official correspondent registered.

US Agent Details

Jessenia Castillo Business: Septodont Email: jcastillo@septodont.com Phone: (800) 8728305

Related Public Records

Same Entity

SEPTODONT

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004443427	SEPTODONT HEALTHCARE INDIA PRIVATE LTD.	VILLAGE-NAVADE, TALUKA-PANVEL Maharashtra, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Similar Registrations

Registration Number	Establishment Name	Location
8030419	SUN MEDICAL CO., LTD.	Moriyama Shiga, JP
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
3035693034	Solventum Germany GmbH	Kist Bavaria, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3003775534	GC EUROPE N.V.	LEUVEN Vlaams Brabant, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610964. Last updated year: 2026. Please use registration number 9610964 when referencing this establishment in official correspondence.