Not currently registered with FDA under this name
Specialites Septodont
Washington, DC, United States. Named as applicant on 19 dental 510(k) clearances between 1985 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 191985–2001
- Markets registered in
- 347 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Specialites Septodont as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Specialites Septodont | 19 clearances | 1985–2001 | Below |
| Colombia | INVIMA | Registration holder | SPECIALITES SEPTODONT S.A.S | 25 | — | Pure Global AI |
| Australia | TGA | Registration holder | Specialites Septodont Pty Ltd | 22 | 2005–2026 | 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
510(k) clearances
Clearances on which FDA names Specialites Septodont as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Oct 2001 | K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | EAT Pulp Tester |
| 23 Jul 2001 | K010415 | ISODAN | KLE Resin Tooth Bonding Agent |
| 3 Nov 1998 | K982773 | QUICKSET LIQUID AND POWDER | EMA Dental Cement |
| 19 Oct 1998 | K982671 | SECURALLOY | EJJ Amalgam Alloy |
| 1 May 1998 | K980633 | ENDOSOLV E | KIF Root Canal Filling Resin |
| 21 Apr 1992 | K920692 | SEPTOCALCINE ULTRA | EJK Calcium Hydroxide Cavity Liner |
| 3 Feb 1992 | K915467 | CIMPAT S DENTAL CEMENT | EMA Dental Cement |
| 3 Feb 1992 | K915466 | SEPTOPACK TEMPORARY FILLING | EBG Resin Temporary Crown and Bridge |
| 7 Nov 1991 | K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | DZM Dental Needle |
| 9 Oct 1991 | K913572 | AUTOPACK NON-EUGENOL PERIODONTAL DRESSING | EMA Dental Cement |
| 30 Sep 1991 | K913574 | SEPTOCAL CAVITY LINER | EJK Calcium Hydroxide Cavity Liner |
| 9 Jul 1990 | K901082 | CYANODONT DENTAL CEMENT | EMA Dental Cement |
| 21 Dec 1989 | K895798 | SILCOT COPAL CAVITY VARNISH | EMA Dental Cement |
| 1 Mar 1989 | K885007 | CIMPAT S TEMPORARY DENTAL CEMENT | EMA Dental Cement |
| 19 Jan 1989 | K884653 | RACESTYPTINE | EKJ Operative Burnisher |
| 15 Jul 1988 | K881890 | PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT | EMA Dental Cement |
| 7 Jun 1988 | K881661 | IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT | EMA Dental Cement |
| 23 Sep 1985 | K851524 | SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE | DZM Dental Needle |
| 29 May 1985 | K851388 | SEPTOSIL SILICONE FOR PRECISION IMPRESSION | ELW Impression Material |
Sources
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 of the most recent filing, which can be a US agent.