BEUDAMED
    FDA Registration Active 🇨🇳 China

    WUXI TP ORTHODONTICS MATERIAL CO., LTD.

    Reg #: 3005537733 · FEI: 3005537733 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    78
    Establishment Types
    2
    Classifications
    9

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    Registration Details

    Registration Name
    WUXI TP ORTHODONTICS MATERIAL CO., LTD.
    Registration Number
    3005537733
    FEI Number
    3005537733
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    L2, A2 BUILDING, LIYUAN ECONOMIC DEVELOPMENT ZONE
    City
    WUXI Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K780619

    Owner / Operator

    Firm Name
    TP ORTHODONTICS, INC.
    Operator Number
    1815540
    Address
    100 CENTER PLAZA, --
    City
    La Porte
    State
    IN
    Postal Code
    46350
    Country
    US

    US Agent

    Business Name
    TP Orthodontics
    Contact Name
    Cristiane Muller
    Address
    100 Center Plaza
    City
    La Porte
    State
    IN
    ZIP
    46350
    Country
    US
    Email
    [email protected]
    Phone
    219 7852591

    Products

    Device Name Product Code
    Band, Elastic, Orthodontic ECI
    Wire, Orthodontic DZC
    Bracket, Metal, Orthodontic EJF
    Strip, Polishing Agent EHM
    Instrument, Ligature Tucking, Orthodontic ECP
    Band, Preformed, Orthodontic ECM
    Positioner, Tooth, Preformed KMY
    Clamp, Wire, Orthodontic ECN
    Bracket, Ceramic, Orthodontic NJM

    Proprietary Names

    Elastomeric Seperators Tru-Force Bump-R-Sleeve tubing Zing String E-Chain Sep-A-Rings Super Slick Elastomeric Ligature ties Elastomeric tubing Mini Stix TPO Elastic thread E-Links Elastomeric thread TPO Latex Elastics Elastomeric ligature ties Elastics Heat Activated Nickel-Titanuim Preformed Archwire TP Original Wire Aesthetic Nickel-Titanuim Preformed Archwire Multi-Strand Preformed Archwire Nickel-Titanuim Preformed Archwire Pre-torqued Preformed Archwire Looped Preformed Archwire Stainless Steel Preformed Archwire Lip Bumper TiMolium Preformed Archwire Bio-Arch Wires Aesthetic Stainless Steel Preformed Archwire Ligature Wire on Spool Preformed Ligature Ties Lip Bumper Coated Lip Bumper with Pads Stainless Steel Straight Archwire VELA Archwire System Bow-Flex Archwire Miscellaneous Wires Tip-Edge Plus NX Tip-Edge Rx-I Begg Metal Bracket Nu-Edge, Straight Edge, Tip Edge, Advant- Edge, Twin-Edge Bracket 256 Begg Bracket Nu-Edge NX Nu-Edge SL Pre-coated Metal bracket Nu-Edge SL Metal Bracket Tip-Edge Plus Metal Nu-Edge II Cobalt Chromium Twin bracket MESIO-DISTAL REDUCER Straight shooter Ligature Applicator PRE-FIT PREFORMED BANDS Molar Band Assemblies Molar Band Pre-Finisher Pre-finisher appliance with seating spring Custom tooth positioner Custom retainer SEPARATION MAINTAINERS CRIMPABLE HOOK Lingual Hook attachments Lingual Button attachments Lingual Cleat attachments RETAINING RINGS Bi level Pin MXI CERAMIC POWER PINS Power Pin CRIMPABLE STOPS RUMELY TRACTION HOOK Aesthetic crimpable stop ELASTIC OUTRIGGER Power hooks Aesthetic crimpable hook TRACT HK W/LIGATING CHAIN ClearVu MXI InVu Plus Ceramic Tip Edge PLUS with pre-applied adhesive InVu with pre-applied adhesive ClearVu with pre-applied adhesive

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device