BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    CEFLA S.C.

    Reg #: 3006610845 · FEI: 3006610845 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    64
    Establishment Types
    3
    Classifications
    15

    Registration Details

    Registration Name
    CEFLA S.C.
    Registration Number
    3006610845
    FEI Number
    3006610845
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA BICOCCA 14/C
    City
    IMOLA Bologna
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K260716

    Owner / Operator

    Firm Name
    CEFLA S.C.
    Operator Number
    9057266
    Address
    Via Bicocca 14/C
    City
    Imola
    State
    Bologna
    Postal Code
    40026
    Country
    IT

    US Agent

    Business Name
    Cefla North America Inc
    Contact Name
    Brett Power
    Address
    6125 Harris Technology Blvd
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US
    Email
    [email protected]
    Phone
    704 7315249

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Unit, Operative Dental EIA
    Sterilizer, Steam FLE
    Device, Pasteurization, Hot Water LDS
    System, X-Ray, Extraoral Source, Digital MUH
    X-Ray, Tomography, Computed, Dental OAS
    Light, Operating, Dental EAZ
    Mouthpiece, Saliva Ejector DYN
    Controller, Foot, Handpiece And Cord EBW
    System, X-Ray, Tomography, Computed JAK
    Chair, Dental, Without Operative Unit NRU
    Unit, X-Ray, Extraoral With Timer EHD
    Locator, Root Apex LQY
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Scaler, Ultrasonic ELC

    Proprietary Names

    Neowise C-U2 Tethys H10 ZEN-Xi X-VS ZEN-X WDS X-POD X-RADiUS COMPACT hyperion X5 NewTom GO X-RADiUS TRiO PLUS NewTom GiANO HR hyperion X9 pro ZEN-X E X-VS E NewTom DCiS NewTom DCiS WL VENUS PLUS L; VENUS PLUS TML-L; VENUS PLUS CL-L; VENUS PLUS CL-M VENUS PLUS. VENUS PLUS TML WS Aerosol Defender i-MMr L i-XS4 handy POWER LED i-MMr L FLUO i-XR3 i-MMs i-XR3 L FLUO i-XR3 L i-XS4 FLUO i-MMr handy POWER LED FLUO handy POWER implantor LED implantor LED FLUO i-MMs FLUO NewTom 5G XL R1 R7. Stern 300 P NordAm NewTom VGi evo NewTom 7G ProXIma X6 NewTom VG-One EOS Compact RX DC Apex Locator NewTom IOS AlphaScan WL VisioScan WR AlphaScan WR MyScan WR MyScan WL VisioScan WL R7 INTERNATIONAL R7 CONTINENTAL R7 R7 P R7 CART R7 M CART R7 M CONTINENTAL R7 M INTERNATIONAL R7 ORTHO PUMA ELI A R M CART; PUMA ELI A R ORTHO; DAMA AMBIDX PUMA ELI A R; PUMA ELI A R CP; PUMA ELI A R CART; PUMA ELI A R M; PUMA ELI A R M CP

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device