BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    ADITEK DO BRASIL, SA

    Reg #: 3003622434 · FEI: 3003622434 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    46
    Establishment Types
    5
    Classifications
    12

    Registration Details

    Registration Name
    ADITEK DO BRASIL, SA
    Registration Number
    3003622434
    FEI Number
    3003622434
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    25, SANTO PIERINI STREET
    City
    CRAVINHOS Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K160957

    Owner / Operator

    Firm Name
    ADITEK DO BRASIL, SA
    Operator Number
    9104741
    Address
    25, SANTO PIERINI STREET, --
    City
    CRAVINHOS
    State
    Sao Paulo
    Postal Code
    14140-000
    Country
    BR
    Correspondent
    EDUARDO - LOPES

    Products

    Device Name Product Code
    Bracket, Metal, Orthodontic EJF
    Spring, Orthodontic ECO
    Handle, Instrument, Dental EJB
    Bracket, Ceramic, Orthodontic NJM
    Aligner, Sequential NXC
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Retainer, Screw Expansion, Orthodontic DYJ
    Wire, Orthodontic DZC
    Instrument, Ligature Tucking, Orthodontic ECP
    Maintainer, Space Preformed, Orthodontic DYT
    Tube, Orthodontic DZD
    Band, Elastic, Orthodontic ECI

    Proprietary Names

    BioClip PI BioClip EasyClip + EasyClip BioMax Vector One Piece Vector+ Vector+ Biocross Niti Open Coil Springs Niti Closed Coil Springs Niti Closed Coil TAD Spring Niti Molar Distalizing Spring Bite Turbo Active Clear+ Clear Aligner (EAB II) Memoflex Copolyester; Memoflex PETG; Memoflex TPU Twist Flex Coaxial Wire Mola Nitinol Distalização Fio Aço Arcos Braided Mola Nitinol aberta Arcos Dupla Chave Fio Elgiloy Arcos de Retração Arcos de Aço Nitinol Contour Niti Mola Nitinol de Retração Arcos TMA Nitinol termoativado Atcos Nitinol Curva Reversa Fio TMA Arcos Nitinol super elastico EasyClip+ opening tool EasyClip+ closing tool Translux Active Clear Slide H5 Safira EasyClip Clear BioCrystal TruSinter Intraoral elastics Elastomerics Stick Tie

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Foreign Private Label Distributor Develop Specifications But Do Not Manufacture At This Facility