BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SABLE INDUSTRIES, INC.

    Reg #: 3002105090 · FEI: 3002105090 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    55
    Establishment Types
    5
    Classifications
    4

    Registration Details

    Registration Name
    SABLE INDUSTRIES, INC.
    Registration Number
    3002105090
    FEI Number
    3002105090
    Status
    Active
    Expiry Year
    2026
    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
    Unit, Suction Operatory EBR
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Unit, Syringe, Air And/Or Water ECB

    Proprietary Names

    TDC 6500 TDC 4500 Rotamax S6500KL Access S4500KL HVE/SE Valve (Suction) FDA Product Code EFB: Sable IS-205 Type 22K 4-Hole Motors w/ Internal A/W FDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Push Button FDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Fiber Optic Ball Bearing w/ Internal Air & Water FDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Switch Latch 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 EGS: Premium Slow Speed Contra-Angles 1:1 Ball Bearing w/ Internal Air & Water FDA Product Code EGS: Sable EC Type 1:1 12-Tooth Contra-Angle FDA Product Code EFB: Premium Slow Speed 20K Air Motors w/ Internal Air & Water FDA Product Code EFB: Sable NSK Type Ball-Bearing Auto Latch-Heads FDA Product Code EFB: Straight air hoses: Type B FDA Product Code EFB: Sable EX-203 Type 22K 4-Hole Air Motors 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: Sable Kavo Type 1:1 Straight Attachments w/ Internal A/W FDA Product Code EFB: Sable EX-6 Type 1:1 Straight Attachments FDA Product Code EFB: Electronic fiber optic control board 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 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 Snap-On Prophy Contra-Angle P/N 1600217 FDA Product Code EGS: Sable E-Type 4:1 Auto-Latch Contra-Angle P/N 1600218 Sable 4:1 Straight Attachments Access Pro NL - 2000017 Rotamax Pro NL - 2000018 Rotamax Pro KL - 2000019 Access Pro KL - 2000020 S600NL NLC400 S700NL Air/Water Syringe RotaMax KL Access KL RotaMax L Access II Straight air hoses Type B or C (ISO 9168) 4 Hole 360 degree Quick-Connect or Multiflex(TM) Couplers Access L Sable 6 Hole, 360 degree Swivel Quick Connect Couplers or Multiflex(TM) Couplers RotaMax II Electronic fiber optic control board Kavo-style 4 Hole and 6 Hole 360 degree Multiflex Couplers 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 Rotamax Pro 45 KL Access K6 Access K4 Rotamax K6 Rotamax K4

    Establishment Types

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