BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dental Imaging Technologies Corporation

    Reg #: 3021551875 · FEI: 3021551875 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    26
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    Dental Imaging Technologies Corporation
    Registration Number
    3021551875
    FEI Number
    3021551875
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    450 Commerce Drive
    City
    Quakertown
    State
    PA
    ZIP
    18951
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233053

    Owner / Operator

    Firm Name
    Dental Imaging Technologies Corporation
    Operator Number
    9007915
    Address
    450 Commerce Drive, --
    City
    Quakertown
    State
    PA
    Postal Code
    18951
    Country
    US
    Correspondent
    Erika Martin

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH
    Unit, Operative Dental EIA
    Unit, X-Ray, Extraoral With Timer EHD
    System, Image Processing, Radiological LLZ
    Holder, Head, Radiographic IWY
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Aligner, Beam, X-Ray EHA
    X-Ray, Tomography, Computed, Dental OAS
    Holder, Film, X-Ray EGZ
    Orthodontic Software PNN

    Proprietary Names

    DEXIS IXS Size 2 Intraoral Sensor DEXIS Ti2 Intraoral Sensor DEXIS IXS Size 1 Intraoral Sensor DEXcam4 HD Dexis Titanium DEXIS IXS Size 1 DEXIS IXS Size 2 NOMAD Pro 3 DEXIS Imaging Suite DEXIS Software NOMAD Pro 2 DEXIS IS 3800W DEXIS IS 3800 DEXIS IS 3700 IOS Scanner Tips DEXIS Imprevo Alignment Bars i-CAT FLX V-Series i-CAT FLX V10 OP 3D Vision V8 OP 3D Vision V17 i-CAT FLX V17 OP 3D Vision V10 i-CAT FLX V8 Imaging Sensor Holder CS Model+

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198