BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    MECTRON S.P.A.

    Reg #: 3003933619 · FEI: 3003933619 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    MECTRON S.P.A.
    Registration Number
    3003933619
    FEI Number
    3003933619
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15, VIA LORETO
    City
    CARASCO Genova
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K122322

    Owner / Operator

    Firm Name
    MECTRON S.P.A.
    Operator Number
    9078459
    Address
    15, VIA LORETO, --
    City
    CARASCO
    State
    Genova
    Postal Code
    16042
    Country
    IT
    Correspondent
    chiara - acunzo

    US Agent

    Business Name
    Piezosurgery Inc. DBA Mectron North America
    Contact Name
    Richelle Braun
    Address
    4115 Leap Rd
    City
    Hilliard
    State
    OH
    ZIP
    43026
    Country
    US
    Email
    [email protected]
    Phone
    817 6021363

    Products

    Device Name Product Code
    Drill, Bone, Powered DZI
    Scaler, Ultrasonic ELC
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Accessories, Implant, Dental, Endosseous NDP
    Activator, Ultraviolet, For Polymerization EBZ
    Airbrush KOJ

    Proprietary Names

    PIEZOSURGERY TOUCH combi touch PIEZOSURGERY GP PIEZOSURGERY FLEX SINUS PHYSIOLIFT II BONE EXPANDERS SINUS PHYSIOLIFT MULTIPIEZO PRO - MULTIPIEZO K10 K6 P16R P15 P16L SLIM SCALER HANDPIECE MT-Bone COMPACT PIEZO LED Starlight Pro Silverlight PIEZOSURGERY 3 - OSSTEMPIEZO PIEZOSURGERY 3 10th ANNIVERSARY LIMITED EDITION Compact Piezo P2K - Powercare PIEZOSURGERY PLUS MT11R-10 MT11L-10

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198