BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    1615E Assistant Arm

    Reg #: 3021741513 · FEI: 3021741513 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AC EQUIPAMENTOS MEDICOS E ODONTOLOGICOS LTDA
    Registration Number
    3021741513
    FEI Number
    3021741513
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rua Antonio Fernandes Figueroa No. 1786, Parque Ind. Lagoinha
    City
    Ribeirao Preto Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K964619

    Owner / Operator

    Firm Name
    AC Equipamentos Medicos e Odontologicos LTDA
    Operator Number
    10057902
    Address
    Rua Zequinha de Abreu # 543
    City
    Ribeirao Preto
    State
    Sao Paulo
    Postal Code
    14095-520
    Country
    BR

    US Agent

    Business Name
    MD Components Inc. DBA Summit Dental Systems
    Contact Name
    Cesar Coral
    Address
    6500 Nw 12th Ave Ste 110
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33309
    Country
    US
    Email
    [email protected]
    Phone
    954 7303636

    Products

    Device Name Product Code
    Unit, Operative Dental EIA

    Proprietary Names

    1615E Assistant Arm SDS Delivery Systems:1402 1607 SDS Cuspidors: 1617 Rear Mounted Assistant Arm SDS Delivery Systems:1407 1615E Daytona Assistant Arm 1660 SDS Cuspidor SDS Delivery Systems:1403

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)