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Data / Medical devices / France / Satelec-Acteon Group

Satelec-Acteon Group: FDA-registered device maker in MERIGNAC Gironde, France, 39 510(k) clearances

Satelec-Acteon Group is registered with the FDA (registration 8044015) in MERIGNAC Gironde, France. It lists 15 device types. The FDA files 39 510(k) clearances under its listings, the newest dated March 11, 2024. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Satelec-Acteon Group
FDA registration number
8044015
FEI number
3004536551
Address
Z.I. Du Phare 17, Avenue Gustave Eiffel, MERIGNAC Gironde, France, 33708
Owner or operator
SATELEC-ACTEON GROUP (9004992)
Roles
Manufacturer, Repackager or relabeler
First device listed
August 2, 1995
Registered through
2027
Brand names listed
Activator Ultraviolet for Polymerization, Air-N-Go by Satelec Air-N-Go Easy by Satelec, BS1S M+ N STER, BS2L M+ N STER, BS2R M+ N STER, BS5 M+ N STER, BS6 M+ N STER, Bone cutting Instrument/Accessories and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Manufactureraccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Manufactureraccessdata.fda.gov
Device, Electrical Dental AnesthesiaLWMUManufactureraccessdata.fda.gov
Drill, Bone, PoweredDZI2Manufactureraccessdata.fda.gov
Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL2Manufactureraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Manufactureraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Manufactureraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Instrument, Surgical, Sonic And Accessory/AttachmentJDX2Manufactureraccessdata.fda.gov
OtoscopeERA1Manufactureraccessdata.fda.gov
Plaque Disclosing KitNYH2Manufactureraccessdata.fda.gov
Scaler, UltrasonicELC2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Unit, Electrosurgical, And Accessories, DentalEKZ2Manufactureraccessdata.fda.gov
Unit, Operative DentalEIA1Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 11, 2024K233922SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONGELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
May 3, 2018K172137PIEZOTOME CUBEDZISubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
May 19, 2017K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceJDXSubstantially EquivalentSatalec-Acteon Groupaccessdata.fda.gov
April 11, 2014K131906SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVEEBZSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
March 11, 2014K132322NEWTRON P5 XS B.LEDELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
March 10, 2014K132267NEWTRON P5, NEWTRON P5 B.LEDELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
January 16, 2014K131151ENDOCENTERELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
November 26, 2013K131997NEWTRON BOOSTERELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
February 23, 2012K113430PROULTRA PIEZO ULTRASONICELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
February 3, 2012K112188PIEZOTOME SOLODZISubstantially EquivalentSatelec - Acteon, Inc.accessdata.fda.gov
January 10, 2012K111623I-ENDO DUALEBWSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
December 8, 2011K110379AIR-N-GOEFBSubstantially EquivalentSatelecaccessdata.fda.gov
April 28, 2010K100410PIEZOELECTRIC SYSTEMJDXSubstantially EquivalentSatelecaccessdata.fda.gov
December 11, 2009K091331PIEZOTOME 2DZISubstantially EquivalentSatelecaccessdata.fda.gov
July 22, 2009K091252IMPLANT CENTER 2DZISubstantially EquivalentSatelecaccessdata.fda.gov
November 19, 2007K072030IMPLANT CENTERDZISubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
September 19, 2007K072181MINI LED AUTOFOCUSEBZSubstantially EquivalentSatelecaccessdata.fda.gov
September 10, 2007K071965I-SURGEEFBSubstantially EquivalentSatelecaccessdata.fda.gov
August 24, 2007K071424PMAX NEWTRON XSELCSubstantially EquivalentSatelec - Acteon Groupaccessdata.fda.gov
May 3, 2006K060275PIEZOTOMEELCSubstantially EquivalentSatelecaccessdata.fda.gov
May 1, 2006K060274PIEZOTOMEDZISubstantially EquivalentSatelecaccessdata.fda.gov
April 20, 2005K050895SURPASSON P5 NEWTRONELCSubstantially EquivalentSatelecaccessdata.fda.gov
December 17, 2004K042787IS 40 MICROMOTOREFBSubstantially EquivalentSatelecaccessdata.fda.gov
August 19, 2004K040529COCOON HYGIENISTEIASubstantially EquivalentSatelecaccessdata.fda.gov
April 28, 2004K040808MINI L.E.D. OEM MODULEEBZSubstantially EquivalentSatelecaccessdata.fda.gov
March 1, 2004K033764SP NEWTRON MODULEELCSubstantially EquivalentSatelecaccessdata.fda.gov
October 21, 2003K032465MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINIEBZSubstantially EquivalentSatelecaccessdata.fda.gov
June 7, 2001K011001TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEMLWMSubstantially EquivalentSatelecaccessdata.fda.gov
April 4, 2000K000049SUNI MAXEFBSubstantially EquivalentSatelecaccessdata.fda.gov
July 10, 1997K972006ACTA OEM MODULEEBZSubstantially EquivalentInteractive Consulting, Inc.accessdata.fda.gov
July 9, 1997K972026SP4044 & SP4055 LUX MODULESELCSubstantially EquivalentSatelecaccessdata.fda.gov
July 31, 1996K961735ACTAEBZSubstantially EquivalentSatelecaccessdata.fda.gov
May 23, 1996K961158SUPRASSON P5 BOOSTERELCSubstantially EquivalentSatelecaccessdata.fda.gov
September 29, 1995K942139SUPRASSON P MAXELCSubstantially EquivalentSatelecaccessdata.fda.gov
December 27, 1985K852522SATALEC SERVOTOMEEKZSubstantially EquivalentSpelna, Inc.accessdata.fda.gov
October 18, 1985K8532005X2 SATALEC CHIROPODY CASESubstantially EquivalentSpelna, Inc.accessdata.fda.gov
March 16, 1984K832674SATELEC PROPHY UNIT PU 2000SELCSubstantially EquivalentSpelna, Inc.accessdata.fda.gov
March 16, 1984K832664SATELEC SUPRASSON PIEZOMATIC P2ELCSubstantially EquivalentSpelna, Inc.accessdata.fda.gov
October 19, 1983K832673SATELEC PROPHY UNIT PU-2000EIASubstantially EquivalentSpelna, Inc.accessdata.fda.gov

Compare with other makers

Updated March 11, 2024. 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.