BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PARAGON IMPLANT MFG., LLC

    Reg #: 3005409899 · FEI: 3005409899 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    PARAGON IMPLANT MFG., LLC
    Registration Number
    3005409899
    FEI Number
    3005409899
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    27030 Malibu Hills Rd
    City
    Calabasas
    State
    CA
    ZIP
    91301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250476

    Owner / Operator

    Firm Name
    Paragon Implant Mfg., LLC
    Operator Number
    10088975
    Address
    27030 Malibu Hills Road
    City
    Calabasas
    State
    CA
    Postal Code
    91301
    Country
    US
    Correspondent
    Renee Bennett

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Accessories, Implant, Dental, Endosseous NDP
    Non-Irrigation Endosseous Dental Implant Drill Bits QRQ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    NizLoc NizPlant Torque Wrench Insert Angle Measuring Guide Hex Tool Drill Extender Hex Latch Driver Torque Wrench Parallelling Guide Pin Removal Tool Drill Stops Hex Drill Crestal Drill Step Drill Starter Drill Linderman Drill GEN5+ Implants and Prosthetics GEN5 Implants and Prosthetics GEN5 and GEN5+ 3.3mm Implants Drill Stop Kit Complete Surgical Kit Prosthetic Kit Empty Standard Surgical Kit Empty

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198