Not currently registered with FDA under this name
Satelec
Merignac, Gironde, France. Named as applicant on 19 dental 510(k) clearances between 1995 and 2011. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 191995–2011
- Markets registered in
- 644 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 6 markets
Where regulators' registries name Satelec 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 | Satelec | 19 clearances | 1995–2011 | Below |
| South Korea | MFDS | Manufacturer | SATELECSATELEC S.A.S · SATELEC. S.A.S · +1 | 24 | 1999–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SATELEC | 9 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SATELEC | 4 | 2015–2019 | Pure Global AI |
| Israel | AMAR | Manufacturer | SATELEC | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SATELECSATELEC S.A.S | 3 | 2006–2012 | 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 Satelec as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Dec 2011 | K110379 | AIR-N-GO | EFB Dental Air-Powered Handpiece |
| 11 Dec 2009 | K091331 | PIEZOTOME 2 | DZI Powered Bone Drill |
| 22 Jul 2009 | K091252 | IMPLANT CENTER 2 | DZI Powered Bone Drill |
| 19 Sep 2007 | K072181 | MINI LED AUTOFOCUS | EBZ Ultraviolet Activator for Polymerization |
| 10 Sep 2007 | K071965 | I-SURGE | EFB Dental Air-Powered Handpiece |
| 3 May 2006 | K060275 | PIEZOTOME | ELC Ultrasonic Scaler |
| 1 May 2006 | K060274 | PIEZOTOME | DZI Powered Bone Drill |
| 25 Jan 2006 | K053328 | BIOSPLINT SPLINTING RIBBON | EBI Rebasing Repairing Relining Denture Resin |
| 20 Apr 2005 | K050895 | SURPASSON P5 NEWTRON | ELC Ultrasonic Scaler |
| 17 Dec 2004 | K042787 | IS 40 MICROMOTOR | EFB Dental Air-Powered Handpiece |
| 19 Aug 2004 | K040529 | COCOON HYGIENIST | EIA Operative Dental Unit |
| 28 Apr 2004 | K040808 | MINI L.E.D. OEM MODULE | EBZ Ultraviolet Activator for Polymerization |
| 1 Mar 2004 | K033764 | SP NEWTRON MODULE | ELC Ultrasonic Scaler |
| 21 Oct 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | EBZ Ultraviolet Activator for Polymerization |
| 4 Apr 2000 | K000049 | SUNI MAX | EFB Dental Air-Powered Handpiece |
| 9 Jul 1997 | K972026 | SP4044 & SP4055 LUX MODULES | ELC Ultrasonic Scaler |
| 31 Jul 1996 | K961735 | ACTA | EBZ Ultraviolet Activator for Polymerization |
| 23 May 1996 | K961158 | SUPRASSON P5 BOOSTER | ELC Ultrasonic Scaler |
| 29 Sep 1995 | K942139 | SUPRASSON P MAX | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: Satelec - Acteon Group (18), DCI International LLC (1), Ultradent Products, Inc. (1), Dentsply Sirona, Inc. (1), KaVo Dental GmbH (1), American Orthodontics (1).
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.