BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOLASE MG LLC

    Reg #: 3017125161 · FEI: 3017125161 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    BIOLASE MG LLC
    Registration Number
    3017125161
    FEI Number
    3017125161
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4225 Prado Road, Suite 102
    City
    Corona
    State
    CA
    ZIP
    92880
    Country
    US

    Regulatory Submissions

    510(k) Number
    K031140

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

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198