BEUDAMED
    FDA Registration Active 🇫🇷 France

    SATELEC-ACTEON GROUP

    Reg #: 8044015 · FEI: 3004536551 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    127
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    SATELEC-ACTEON GROUP
    Registration Number
    8044015
    FEI Number
    3004536551
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Z.I. DU PHARE, 17, AVENUE GUSTAVE EIFFEL
    City
    MERIGNAC Gironde
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K132267

    Owner / Operator

    Firm Name
    SATELEC-ACTEON GROUP
    Operator Number
    9004992
    Address
    1001 Briggs Rd, Suite 220
    City
    Mount Laurel
    State
    NJ
    Postal Code
    08054
    Country
    US
    Correspondent
    Noelle Zuccarello

    US Agent

    Business Name
    Acteon, Inc
    Contact Name
    Noelle Zuccarello
    Address
    1001 Briggs Rd
    City
    Mount Laurel
    State
    NJ
    ZIP
    08054
    Country
    US
    Email
    [email protected]
    Phone
    800 2896367 ext. 280

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC
    Drill, Bone, Powered DZI
    Otoscope ERA
    Device, Electrical Dental Anesthesia LWM
    Unit, Operative Dental EIA
    Controller, Foot, Handpiece And Cord EBW
    Activator, Ultraviolet, For Polymerization EBZ
    Handpiece, Air-Powered, Dental EFB
    Unit, Electrosurgical, And Accessories, Dental EKZ
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Plaque Disclosing Kit NYH
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    NEWTRON P5 B.LED NEWTRON P5 Drill, Bone, Powered PIEZOTOME SOLO PIEZOTOME SOLO LED Otoscope Device Electrical Dental Anesthesia Scaler Ultrasonic Unit Operative Dental EVOS Dental Hand-Piece and Accessories ENDO Dual i-endo dual dental motor, endo motion PIEZOTOME CUBE PIEZOTOME Drill, Bone , Powered MINI-LED AF OEM MINI-LED AF Newtron P5 XS B.LED Satelec Newtron P5 XS B.LED Satelec Newtron P5 XS Satelec Newtron P5 XS / P5 XS B.LED Newtron P5 XS EDGETIP - #1, #2, #3, #4, #5, #6, #7, #8 Endo Tips - ETBD, ET18D, ET20D, ET40D, ET25S, ET25, ET25L EDGESURGICALTIP - #1, #2, #3, #4, #5, #6 Surgical Tips - AS3D, P15LD, ASLD, P15RD, ASRD Air-N-Go by Satelec Air-N-Go Easy by Satelec handpiece Air Powered Dental Scanwave Pen OEM NWT CAN SLIM LED CORD G3 SHORT SP NEWTRON CAN A NWT CAN SLIM LED CORD G3 LONG MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; Unit Electrosurgical and Accessories Dental SMARTLITE Mini L.E.D. , Celalux 2 Mini-Led Black MINI-LED SUPER CHARGEED MINI-L.E.D. SP MINI-L.E.D. ORTHRO 2 MINI L.E.D. OEM MINI-LED BLUE RAY 2 MINI-L.E.D. REGULAR MINI LED BLUE RAY 3 IMPLANT CENTER 2 Implant Center 2 with I-Surge LED motor Drill, bONE, pOWERED Handpiece Air Powered Dental ProUltra Piezo Ultrasonic Satelec ProUltra Piezo Ultrasonic PIEZOTOME M+ Bone Surgery Tips PIEZOTOME M+ Bone Surgery Tips: RHS1, RHS2Fb, RHS2Hb, RHS3L, RHS3R, RHS4L, RHS4R, RHS5, RHL5, RHS6 NINJA M+ N STER CE2 M+ N STER INSERT BS1 RD M+ N STER INSERT SL2 M+ N STER INSERT BS2L XL M+ N STER SL4 M+ N STER INSERT BS1 XXL M+ N STER BS5 M+ N STER PIEZOTOME SOLO M+ US LC1 XL M+ N STER SL5 M+ N STER KIT RHS EXPERT M+ N STER LC1 M+ N STER INSERT BS2R XL M+ N STER CS6 M+ N STER INSERT BS6 XXL M+ N STER TKW5 M+ N STER INSERT SL3 M+ N STER KIT CMF NON STERILE TIP RHS3L M+ N STER INSERT SL1 M+ N STER TKW4 M+ N STER CS4 M+ N STER LC2 M+ N STER INSERT BS4 M+ N STER INSERT RHS4L N STER TKW2 M+ N STER CE3 M+ N STER INSERT RHS2Fb N STER CS1 M+ N STER BS1S M+ N STER INSERT RHS2Hb N STER TKW1 M+ N STER TIP RHS5 M+ N STER CS2 M+ N STER TKW3 M+ N STER DB 2 M+ N STER CS3 M+ N STER CE1 M+ N STER TIP RHS6 M+ N STER TIP RHS3R M+ N STER BS2R M+ N STER INSERT RHS4R N STER KIT RHS BASIC M+ N STER BS6 M+ N STER INSERT BS1L M+ N STER LC2R M+ N STER BS2L M+ N STER INSERT RHS1 N STER LC2L M+ N STER CS5 M+ N STER DB 1 M+ N STER RHL4R M+ RHL5 M+ RHL6 M+ RHL2 RHL4L M+ FLAG FOR B.LED SATELEC FLAG FOR B.LED Activator Ultraviolet for Polymerization Newtron Booster Ultrasonic Scaler MINI L.E.D SUPERCHARGED O.E.M ULTRAWAVE xs ULTRAWAVE P5 Newtron XS PIEZOTOME M+ Craniomaxillofacial Surgery Tips: SL3 -- BS6 XXL -- BS4 --SL2 -- SL1 -- BS2R XL -- BS2L XL -- BS1 XXL -- BS1L -- BS1RD Scaler Ultrasonic Device Bone cutting Instrument/Accessories Piezotome 2 Piezoelectric System Scaler Ultra Sonic EndoCenter

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device