BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    RotaMax L

    Reg #: 3002105090 · FEI: 3002105090 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SABLE INDUSTRIES, INC.
    Registration Number
    3002105090
    FEI Number
    3002105090
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Campbell Avenue, Suite 5
    City
    Kitchener Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K072554

    Owner / Operator

    Firm Name
    Sable Industries, Inc.
    Operator Number
    10024322
    Address
    100 Campbell Avenue, Suite 5
    City
    Kitchener
    State
    Ontario
    Postal Code
    N2H 4X8
    Country
    CA
    Correspondent
    Jeff DaSilva

    US Agent

    Business Name
    ComplianceAcuity, Inc
    Contact Name
    Kevin Randall
    Address
    485 Clinton St, #888
    City
    Ridgeway
    State
    CO
    ZIP
    81432
    Country
    US
    Email
    [email protected]
    Phone
    303 8280844

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    RotaMax L RotaMax KL Access L Access KL Kavo-style 4 Hole and 6 Hole 360 degree Multiflex Couplers 4 Hole 360 degree Quick-Connect or Multiflex(TM) Couplers RotaMax II Electronic fiber optic control board Sable 6 Hole, 360 degree Swivel Quick Connect Couplers or Multiflex(TM) Couplers Access II Straight air hoses Type B or C (ISO 9168) RotaMax Pro KL Kavo Interchangeable Fiber Optic Torque Head P/N 2000022 Access Pro KL Kavo Interchangeable Fiber Optic Mini Head P/N 2000021 Rotamax Pro 45 KL Rotamax Pro 45 Rotamax K4 Access K4 Access K6 Rotamax K6

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device