BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mectron North America

    Reg #: 3005282635 · FEI: 3005282635 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    8

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    Registration Details

    Registration Name
    Mectron North America
    Registration Number
    3005282635
    FEI Number
    3005282635
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4115 Leap Rd
    City
    Hilliard
    State
    OH
    ZIP
    43026
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140965

    Owner / Operator

    Firm Name
    Piezosurgery, Inc DBA Mectron North America
    Operator Number
    9075679
    Address
    4115 Leap Road
    City
    Hilliard
    State
    OH
    Postal Code
    43026
    Country
    US
    Correspondent
    Richelle Braun

    Products

    Device Name Product Code
    Scaler, Ultrasonic ELC
    Drill, Bone, Powered DZI
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    MULTIPIEZO, MULTIPIEZO PRO COMPACT PIEZO LED Piezosurgery Touch SteriZign Piezosurgery // MT-Bone Piezosurgery Flex WISER Piezosurgery GP Device Piezosurgery Plus Piezosurgery Medical Piezosurgery 3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198