BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    FDA Product Code EFB: Sable Kavo Type 1:1 Straight Attachments w/ Internal A/W

    Reg #: 3002105090 · FEI: 3002105090 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    2

    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
    K083101

    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
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS

    Proprietary Names

    FDA Product Code EFB: Sable Kavo Type 1:1 Straight Attachments w/ Internal A/W FDA Product Code EGS: Sable Kavo Type 1:1 Contra-Angle w/ Internal A/W FDA Product Code EFB: Sable Kavo Type 1:1 Ball-Bearing Auto Latch-Heads FDA Product Code EFB: Straight air hoses: Type B FDA Product Code EFB: Electronic fiber optic control board FDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Fiber Optic Ball Bearing w/ Internal Air & Water FDA Product Code EFB: Sable IS-205 Type 22K 4-Hole Motors w/ Internal A/W FDA Product Code EFB: Sable NAC Type Standard Swing Latch-Heads FDA Product Code EFB: Premium Slow Speed Straight Nosecones 1:1 Ball Bearing w/ Internal Air & Water FDA Product Code EFB: Sable EX-6 Type 1:1 Straight Attachments FDA Product Code EFB: Sable NSK Type Ball-Bearing Auto Latch-Heads FDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Switch Latch FDA Product Code EFB: Premium Slow Speed 20K Air Motors w/ Internal Air & Water FDA Product Code EGS: Sable EC Type 1:1 12-Tooth Contra-Angle FDA Product Code EFB: Sable EX-203 Type 22K 4-Hole Air Motors FDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Ball Bearing w/ Internal Air & Water FDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Push Button FDA Product Code EGS: Sable E-Type 4:1 Snap-On Prophy Contra-Angle P/N 1600217 FDA Product Code EGS: Sable E-Type 1:1 Ball-Bearing PB FG Contra-Angle P/N 1600215 FDA Product Code EGS: Sable E-Type 4:1 Auto-Latch Contra-Angle P/N 1600218 FDA Product Code EGS: Sable E-Type 1:1 Ball-Bearing Auto-Latch Contra-Angle P/N 1600214 FDA Product Code EGS: Sable E-Type 4:1 Screw-In Prophy Contra-Angle P/N 1600216 Sable 4:1 Straight Attachments

    Establishment Types

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