BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    CEPHX, CEPHX- Cephalometric Analysis Software

    Reg #: 3030655434 · FEI: 3030655434 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORCA DENTAL AI
    Registration Number
    3030655434
    FEI Number
    3030655434
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Dolev St.4
    City
    Ra'anana Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K231396

    Owner / Operator

    Firm Name
    Orca Dental AI
    Operator Number
    10090134
    Address
    10 Hamanofin St.
    City
    Herzliya
    State
    Central
    Postal Code
    4672561
    Country
    IL
    Correspondent
    Moshe Melamed

    US Agent

    Business Name
    FDAbasics LLC
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd.
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    CEPHX, CEPHX- Cephalometric Analysis Software

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198