BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOLASE MG LLC

    Reg #: 2027755 · FEI: 2027755 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    BIOLASE MG LLC
    Registration Number
    2027755
    FEI Number
    2027755
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    27042 Towne Centre Drive, Suite 270
    City
    Foothill Ranch
    State
    CA
    ZIP
    92610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101658

    Owner / Operator

    Firm Name
    MEGAGEN IMPLANT CO. LTD
    Operator Number
    9067358
    Address
    45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
    City
    Daegu
    State
    KR-NOTA
    Postal Code
    42921
    Country
    KR
    Correspondent
    Kwang Bum Park

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Laser, Dental, Soft Tissue NVK
    Drill, Bone, Powered DZI
    System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation MXF

    Proprietary Names

    WL iPlus/MDX WL MDTurbo/Turbo HP Epic Pro 980 WL Express Epic Hygiene Epic X/10/T-Series Epic Pro 940 Waterlase iPlus with Fractional Handpiece EdgePro Epic S- Series Powered Laser Surgical Instrument iLase

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility