Manufacturer registered with FDA
Satelec - Acteon Group
Mount Laurel, NJ, United States. Lists 14 dental device types with FDA across 3 registered establishments, and holds 18 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 97
- 510(k) clearances
- 181999–2024
- Markets registered in
- 1181 registrations outside the US
- Establishments
- 3France, United States
510(k) clearances per year, 1990–2026
Registered in 11 markets
Where regulators' registries name Satelec - Acteon Group as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Satelec - Acteon Group | 18 clearances | 1999–2024 | Below |
| Australia | TGA | Manufacturer | Sopro | 25 | 2007–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SOPRO | 16 | 2002–2015 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SOPRO | 13 | 2006–2014 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SOPRO | 8 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SOPRO | 7 | 2022–2023 | Pure Global AI |
| China | NMPA | Registration holder | 摄谱乐公司SOPRO | 3 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SOPRO | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | SOPRO | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SOPRO S.A. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SOPRO S.A. | 1 | 2015–2015 | 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 Satelec - Acteon Group currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | EDGESURGICALTIP - #1, #2, #3, #4, #5, #6EDGETIP - #1, #2, #3, #4, #5, #6, #7, #8Endo Tips - ETBD, ET18D, ET20D, ET40D, ET25S, ET25, ET25LEndoCenterMODULE NEWTRON CAN-A EMB;Newtron BoosterNEWTRON P5NEWTRON P5 B.LEDNewtron P5 XSNewtron P5 XS B.LED 17 moreNWT CAN SLIM LED CORD G3 LONGNWT CAN SLIM LED CORD G3 SHORTP5 Newtron XSProUltra Piezo UltrasonicSatelec Newtron P5 XSSatelec Newtron P5 XS / P5 XS B.LEDSatelec Newtron P5 XS B.LEDSatelec ProUltra Piezo UltrasonicScaler Ultra SonicScaler UltrasonicScaler Ultrasonic DeviceSP NEWTRON CAN ASUPPORT XINETIC;Surgical Tips - AS3D, P15LD, ASLD, P15RD, ASRDUltrasonic ScalerULTRAWAVEULTRAWAVE xs | 2007 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Bone cutting Instrument/AccessoriesCraniomaxillofacial Surgery Tips: SL3 -- BS6 XXL -- BS4 --SL2 -- SL1 -- BS2R XL -- BS2L XL -- BS1 XXL -- BS1L -- BS1RDDrill, Bone , PoweredDrill, Bone, PoweredIMPLANT CENTER 2Implant Center 2 with I-Surge LED motorPiezoelectric SystemPIEZOTOMEPiezotome 2PIEZOTOME CUBE 5 morePIEZOTOME M+PIEZOTOME SOLOPIEZOTOME SOLO LEDPZ1 IIPZ3 II | 2006 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Activator Ultraviolet for PolymerizationMINI L.E.D SUPERCHARGED O.E.MMini L.E.D. , Celalux 2MINI L.E.D. OEMMINI LED BLUE RAY 3MINI-L.E.D. ORTHRO 2MINI-L.E.D. REGULARMINI-L.E.D. SPMINI-LED AFMINI-LED AF OEM 5 moreMini-Led BlackMINI-LED BLUE RAY 2MINI-LED SUPER CHARGEEDScanwave Pen OEMSMARTLITE | 2007 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Mini Dock U USB2Mini Dock USB2S-575 Intraoral Docking Dental CameraS575 INTRAORAL DOCKING DENTAL CAMERSOPRO 595 INTRA ORAL CAMERASOPRO 617 INTRA OTAL CAMERASOPRO 717 FIRSTSOPRO 717 INTRA ORAL CAMERASOPRO S555 INTRAORAL DENTAL CAMERAUnit Operative Dental | 2007 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | PSPIX2SOPIXSOPIX 2SOPIX INSIDE, SOPIX2 INSIDESOPIX PLUG-IN, SOPIX2 PLUG-INSopro PSPIXSOPRO SOPIX | 2009 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Air-N-Go by Satelec Air-N-Go Easy by Satelechandpiece Air Powered Dental | 2007 |
| Light-Induced Fluorescence Caries DetectorNBL · Class 2 | Caries detection devices | Maker | C50Caries Detection DeviceLaser Flourescence Caries DetectionMini Dock U USB2Mini Dock USB2SOPROLIFE | 2010 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | Riskontrol | 2002 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | EndoCenterI-SURGE +Scaler Ultra Sonic | 2011 |
| Plaque Disclosing KitNYH · Class 2 | — | Maker | FLAG FOR B.LED SATELEC FLAG FOR B.LEDMini Dock U USB2Mini Dock USB2 | 2013 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Dental Hand-Piece and AccessoriesENDO DualEVOSi-endo dual dental motor, endo motion | 2014 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Lister | Sopro PSPIX | 2009 |
| Dental Electrosurgical Unit and AccessoriesEKZ · Class 2 | — | Maker | Unit Electrosurgical and Accessories Dental | 2008 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | C20 INTRAORAL CAMERAC50 INTRAORAL CAMERA D | 2025 |
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 Satelec - Acteon Group as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Mar 2024 | K233922 | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG | ELC Ultrasonic Scaler |
| 14 Dec 2023 | K223470 | C50 | NBL Light-Induced Fluorescence Caries Detector |
| 3 May 2018 | K172137 | PIEZOTOME CUBE | DZI Powered Bone Drill |
| 11 Apr 2014 | K131906 | SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE | EBZ Ultraviolet Activator for Polymerization |
| 11 Mar 2014 | K132322 | NEWTRON P5 XS B.LED | ELC Ultrasonic Scaler |
| 10 Mar 2014 | K132267 | NEWTRON P5, NEWTRON P5 B.LED | ELC Ultrasonic Scaler |
| 16 Jan 2014 | K131151 | ENDOCENTER | ELC Ultrasonic Scaler |
| 26 Nov 2013 | K131997 | NEWTRON BOOSTER | ELC Ultrasonic Scaler |
| 12 Mar 2013 | K121685 | SOPROCARE | NBL Light-Induced Fluorescence Caries Detector |
| 23 Feb 2012 | K113430 | PROULTRA PIEZO ULTRASONIC | ELC Ultrasonic Scaler |
| 10 Jan 2012 | K111623 | I-ENDO DUAL | EBW Handpiece and Cord Foot Controller |
| 20 Jul 2010 | K092329 | SOPIX 2 | MUH Digital Extraoral Source X-Ray System |
| 13 Jan 2010 | K092583 | SOPROLIFE | NBL Light-Induced Fluorescence Caries Detector |
| 19 Nov 2007 | K072030 | IMPLANT CENTER | DZI Powered Bone Drill |
| 24 Aug 2007 | K071424 | PMAX NEWTRON XS | ELC Ultrasonic Scaler |
| 5 Oct 2001 | K012505 | SOPRO595 INTRA ORAL CAMERA | EIA Operative Dental Unit |
| 21 Apr 1999 | K990948 | S575 INTRAORAL DOCKING DENTAL CAMERA | EIA Operative Dental Unit |
| 11 Jan 1999 | K983625 | S555 INTRAORAL DENTAL CAMERA | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: DCI International LLC (2), A-dec, Inc. (1), HSG-S Corp (1).
Also lists devices cleared under other names
Satelec - Acteon Group 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: Satelec (18), Spelna, Inc. (4), Sopro - Acteon Group (3), Satelec - Acteon, Inc. (1), By Dental Srl (1), Soredex Palodex Group OY (1), Interactive Consulting, Inc. (1), Riskontrol (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Aug 2015 | K142995 | SOPIX | Sopro - Acteon Group | MUH Digital Extraoral Source X-Ray System |
| 31 Jul 2015 | K151053 | PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner | Sopro - Acteon Group | MUH Digital Extraoral Source X-Ray System |
| 5 Sep 2014 | K140013 | SOPIX INSIDE, SOPIX2 INSIDE | Sopro - Acteon Group | MUH Digital Extraoral Source X-Ray System |
| 3 Feb 2012 | K112188 | PIEZOTOME SOLO | Satelec - Acteon, Inc. | DZI Powered Bone Drill |
| 8 Dec 2011 | K110379 | AIR-N-GO | Satelec | EFB Dental Air-Powered Handpiece |
| 11 Dec 2009 | K091331 | PIEZOTOME 2 | Satelec | DZI Powered Bone Drill |
| 30 Oct 2009 | K091913 | HI TECH IMPLANT, HT PHYSIO IMPLANT | By Dental Srl | EKX Ac-Powered Direct Drive Handpiece |
| 22 Jul 2009 | K091252 | IMPLANT CENTER 2 | Satelec | DZI Powered Bone Drill |
| 19 Sep 2007 | K072181 | MINI LED AUTOFOCUS | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 10 Sep 2007 | K071965 | I-SURGE | Satelec | EFB Dental Air-Powered Handpiece |
| 3 May 2006 | K060275 | PIEZOTOME | Satelec | ELC Ultrasonic Scaler |
| 1 May 2006 | K060274 | PIEZOTOME | Satelec | DZI Powered Bone Drill |
| 20 Apr 2005 | K050895 | SURPASSON P5 NEWTRON | Satelec | ELC Ultrasonic Scaler |
| 17 Dec 2004 | K042787 | IS 40 MICROMOTOR | Satelec | EFB Dental Air-Powered Handpiece |
| 19 Aug 2004 | K040529 | COCOON HYGIENIST | Satelec | EIA Operative Dental Unit |
| 15 Jun 2004 | K041050 | DIGORA OPTIME (OR DIGORA ONTIME) | Soredex Palodex Group OY | MUH Digital Extraoral Source X-Ray System |
| 28 Apr 2004 | K040808 | MINI L.E.D. OEM MODULE | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 1 Mar 2004 | K033764 | SP NEWTRON MODULE | Satelec | ELC Ultrasonic Scaler |
| 21 Oct 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 4 Apr 2000 | K000049 | SUNI MAX | Satelec | EFB Dental Air-Powered Handpiece |
| 10 Jul 1997 | K972006 | ACTA OEM MODULE | Interactive Consulting, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 9 Jul 1997 | K972026 | SP4044 & SP4055 LUX MODULES | Satelec | ELC Ultrasonic Scaler |
| 31 Jul 1996 | K961735 | ACTA | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 23 May 1996 | K961158 | SUPRASSON P5 BOOSTER | Satelec | ELC Ultrasonic Scaler |
| 29 Sep 1995 | K942139 | SUPRASSON P MAX | Satelec | ELC Ultrasonic Scaler |
| 5 Apr 1993 | K923876 | RISKONTROL SINGLE USE | Riskontrol | ECB Air and/or Water Syringe Unit |
| 27 Dec 1985 | K852522 | SATALEC SERVOTOME | Spelna, Inc. | EKZ Dental Electrosurgical Unit and Accessories |
| 16 Mar 1984 | K832664 | SATELEC SUPRASSON PIEZOMATIC P2 | Spelna, Inc. | ELC Ultrasonic Scaler |
| 16 Mar 1984 | K832674 | SATELEC PROPHY UNIT PU 2000S | Spelna, Inc. | ELC Ultrasonic Scaler |
| 19 Oct 1983 | K832673 | SATELEC PROPHY UNIT PU-2000 | Spelna, Inc. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ACTEON, INC.FDA reg. 2243757 | Mount Laurel, NJ, United States | Repacker / relabeler |
| SATELEC-ACTEON GROUPFDA reg. 8044015 | MERIGNAC Gironde, France | Manufacturer, Repacker / relabeler |
| SOPROFDA reg. 9615782 | LA CIOTAT CEDEX Bouches-du-Rhone, France | Manufacturer, Repacker / relabeler |
Other names on FDA records
Sopro S.A. · Acteon, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9004992). 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.