BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    S.I.N. Implant System Ltda

    Reg #: 3004201263 · FEI: 3004201263 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    S.I.N. Implant System Ltda
    Registration Number
    3004201263
    FEI Number
    3004201263
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rua Soldador Ocimar Guimaraes da Silva 421, Jardim Analia Franco
    City
    SAO PAULO
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K212404

    Owner / Operator

    Firm Name
    S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A
    Operator Number
    9059509
    Address
    Soldador Ocimar Guimaraes da Silva Street, 421, Vereador Abel Ferreira Avenue, 2140 (only social entrance)
    City
    Sao Paulo
    State
    BR-SP
    Postal Code
    03348-060
    Country
    BR

    US Agent

    Business Name
    PAXMED INTERNATIONAL, LLC
    Contact Name
    Floyd Larson
    Address
    1925 Palomar Oaks Way Ste 210
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US
    Email
    [email protected]
    Phone
    858 7921235

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Accessories, Implant, Dental, Endosseous NDP
    Retractor, All Types EIG

    Proprietary Names

    S.I.N. Instrument Kits S.I.N. Dental Implant System Sistema de Implante Nacional (S. I. N.) Dental Implant System BioHorizons Sistema de Implante Nacional (S. I. N.) Dental Implant Accessories S.I.N. Instrument Kit Cheek Retractor

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)