BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ORCA DENTAL AI

    Reg #: 3030655434 · FEI: 3030655434 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ORCA DENTAL AI
    Registration Number
    3030655434
    FEI Number
    3030655434
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5, Hatidhar
    City
    Ra'anana Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K252538

    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
    Orca Dental AI LLC
    Contact Name
    Moshe Melamed
    Address
    8 The Grn # 20338
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    800 9921499

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    CEPHX3D CEPHX, CEPHX- Cephalometric Analysis Software

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device