BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EXOCAD AMERICA, INC.

    Reg #: 3013718526 · FEI: 3013718526 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    EXOCAD AMERICA, INC.
    Registration Number
    3013718526
    FEI Number
    3013718526
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    301 Edgewater Pl Ste 330
    City
    Wakefield
    State
    MA
    ZIP
    01880
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193352

    Owner / Operator

    Firm Name
    exocad GmbH
    Operator Number
    10055196
    Address
    Rosa-Parks-Str. 2
    City
    Darmstadt
    State
    Hesse
    Postal Code
    64295
    Country
    DE
    Correspondent
    Stefan O Walter

    Products

    Device Name Product Code
    Dental Abutment Design Software For Dental Laboratory PNP
    Medical Device Data System OUG
    System, Image Processing, Radiological LLZ
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    AbutmentCAD Implant Module Ceramill Mind M-Plant PlanCAD Premium AbutmentCAD DentalDB exoplan ChairsideCAD Ceramill Mind DRS

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198