BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ORTHODONTIC MANUFACTURER SIA SRL

    Reg #: 9710113 · FEI: 3003348399 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    15

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    Registration Details

    Registration Name
    ORTHODONTIC MANUFACTURER SIA SRL
    Registration Number
    9710113
    FEI Number
    3003348399
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ZONA INDUSTRIALE, VIA VANDRA
    City
    ROCCA D EVANDRO Caserta
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K961754

    Owner / Operator

    Firm Name
    ORTHODONTIC MANUFACTURER SIA SRL
    Operator Number
    9080887
    Address
    ZONA INDUSTRIALE, --
    City
    ROCCA D'EVANDRO (CE)
    State
    Caserta
    Postal Code
    81040
    Country
    IT

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Katie Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Plier, Orthodontic JEX
    Tube, Orthodontic DZD
    Headgear, Extraoral, Orthodontic DZB
    Bracket, Metal, Orthodontic EJF
    Clamp, Wire, Orthodontic ECN
    Facebow KCR
    Gauge, Depth, Instrument, Dental EIL
    Band, Material, Orthodontic DYO
    Spring, Orthodontic ECO
    Wire, Orthodontic DZC
    Band, Preformed, Orthodontic ECM
    Maintainer, Space Preformed, Orthodontic DYT
    Pusher, Band, Orthodontic ECS
    Band, Elastic, Orthodontic ECI
    Retainer, Screw Expansion, Orthodontic DYJ

    Proprietary Names

    SIA ORTHODONTIC MANUFACTURER JET JET LP ZIP T7 ZIP T6 SUPERTECH MICROFIT BT2 - BITURBO ZIP TS2 - ZIP LP HEXAGON SLIDING AND CRIMPABLE HOOKS CRIMPABLE STOP FACEBOW INTERPROXIMAL INCREMENTAL GAUGE IPR MACH3 I-ARCH ACTIVA D-bar SVOP SMART CLICK LEONARDO PALATAL EXPANDER XP PALATAL EXPANDER

    Establishment Types

    Manufacture Medical Device