Data / Medical devices / France / Septodont
Septodont: FDA-registered device maker in CEDEX Val-de-Marne, France, 8 510(k) clearances
Septodont is registered with the FDA (registration 9610964) in CEDEX Val-de-Marne, France. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 16, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610964
- FEI number
- 1000477999
- Address
- 58, Rue Du Pont De Creteil Saint Maur Des Fosses, CEDEX Val-de-Marne, France, 94107
- Owner or operator
- SEPTODONT (8010102)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 30, 1985
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2021 | K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | KIF | Substantially Equivalent | Septodont | accessdata.fda.gov |
| August 10, 2021 | K211799 | Biodentine XP 500, Biodentine XP 200 | KIF | Substantially Equivalent | Septodont | accessdata.fda.gov |
| June 27, 2014 | K140132 | BIODENTINE | KIF | Substantially Equivalent | Septodont | accessdata.fda.gov |
| October 17, 2013 | K130601 | BIOROOT RCS | KIF | Substantially Equivalent | Novocol, Inc. | accessdata.fda.gov |
| February 17, 2010 | K093711 | RACEGEL | MVL | Substantially Equivalent | Septodont | accessdata.fda.gov |
| May 11, 2007 | K063634 | RTR SYRINGE | LYC | Substantially Equivalent | Septodont | accessdata.fda.gov |
| July 11, 1995 | K945843 | SAFETY PLUS | EJI | Substantially Equivalent | Arent Fox | accessdata.fda.gov |
| March 1, 1983 | K830117 | ENDOMET | EMA | Substantially Equivalent | North Pacific Dental, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Root Canal Filling
- All makers of Needle, Dental
- All makers of Cement, Dental
- All makers of Bone Grafting Material, Synthetic
- All makers of Syringe, Cartridge
- All makers of Cord, Retraction
Updated September 16, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.