Manufacturer registered with FDA
Sable Industries, Inc.
Kitchener, Canada. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 78
- 510(k) clearances
- 22007–2009
- Markets registered in
- 347 registrations outside the US
- Establishments
- 1Canada
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Sable Industries, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: CanadaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sable Industries, Inc. | 2 clearances | 2007–2009 | Below |
| Canada | Health Canada | Registration holder | SABLE INDUSTRIES INC. | 46 | 2006–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Sable Industries | 1 | 2001–2001 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Sable Industries, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Access IIAccess K4Access K6Access KLAccess LAccess Pro KL - 2000020Access Pro KL Kavo Interchangeable Fiber Optic Mini Head P/N 2000021Access Pro NL - 2000017Access S4500KLElectronic fiber optic control board 43 moreFDA Product Code EFB: Electronic fiber optic control boardFDA Product Code EFB: Premium Slow Speed 20K Air Motors w/ Internal Air & WaterFDA Product Code EFB: Premium Slow Speed Straight Nosecones 1:1 Ball Bearing w/ Internal Air & WaterFDA Product Code EFB: Sable EX-203 Type 22K 4-Hole Air MotorsFDA Product Code EFB: Sable EX-6 Type 1:1 Straight AttachmentsFDA Product Code EFB: Sable IS-205 Type 22K 4-Hole Motors w/ Internal A/WFDA Product Code EFB: Sable Kavo Type 1:1 Ball-Bearing Auto Latch-HeadsFDA Product Code EFB: Sable Kavo Type 1:1 Straight Attachments w/ Internal A/WFDA Product Code EFB: Sable NAC Type Standard Swing Latch-HeadsFDA Product Code EFB: Sable NSK Type Ball-Bearing Auto Latch-HeadsFDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Push ButtonFDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Switch LatchFDA Product Code EFB: Straight air hoses: Type BFDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Ball Bearing w/ Internal Air & WaterFDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Fiber Optic Ball Bearing w/ Internal Air & WaterFDA Product Code EGS: Sable E-Type 1:1 Ball-Bearing Auto-Latch Contra-Angle P/N 1600214FDA Product Code EGS: Sable E-Type 1:1 Ball-Bearing PB FG Contra-Angle P/N 1600215FDA Product Code EGS: Sable E-Type 4:1 Auto-Latch Contra-Angle P/N 1600218FDA Product Code EGS: Sable E-Type 4:1 Screw-In Prophy Contra-Angle P/N 1600216FDA Product Code EGS: Sable E-Type 4:1 Snap-On Prophy Contra-Angle P/N 1600217FDA Product Code EGS: Sable EC Type 1:1 12-Tooth Contra-AngleFDA Product Code EGS: Sable Kavo Type 1:1 Contra-Angle w/ Internal A/WKavo-style 4 Hole and 6 Hole 360 degree Multiflex CouplersNLC400RotaMax IIRotamax K4Rotamax K6RotaMax KLRotaMax LRotamax Pro 45Rotamax Pro 45 KLRotamax Pro KL - 2000019RotaMax Pro KL Kavo Interchangeable Fiber Optic Torque Head P/N 2000022Rotamax Pro NL - 2000018Rotamax S6500KLS600NLS700NLSable 4:1 Straight AttachmentsSable 6 Hole, 360 degree Swivel Quick Connect Couplers or Multiflex(TM) CouplersStraight air hoses Type B or C (ISO 9168)TDC 4500TDC 65004 Hole 360 degree Quick-Connect or Multiflex(TM) Couplers | 2008 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | HVE/SE Valve (Suction) | 2023 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Air/Water Syringe | 2023 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | FDA Product Code EFB: Electronic fiber optic control boardFDA Product Code EFB: Premium Slow Speed 20K Air Motors w/ Internal Air & WaterFDA Product Code EFB: Premium Slow Speed Straight Nosecones 1:1 Ball Bearing w/ Internal Air & WaterFDA Product Code EFB: Sable EX-203 Type 22K 4-Hole Air MotorsFDA Product Code EFB: Sable EX-6 Type 1:1 Straight AttachmentsFDA Product Code EFB: Sable IS-205 Type 22K 4-Hole Motors w/ Internal A/WFDA Product Code EFB: Sable Kavo Type 1:1 Ball-Bearing Auto Latch-HeadsFDA Product Code EFB: Sable Kavo Type 1:1 Straight Attachments w/ Internal A/WFDA Product Code EFB: Sable NAC Type Standard Swing Latch-HeadsFDA Product Code EFB: Sable NSK Type Ball-Bearing Auto Latch-Heads 13 moreFDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Push ButtonFDA Product Code EFB: Slow Speed & Premium Slow Speed Heads Ball Bearing Switch LatchFDA Product Code EFB: Straight air hoses: Type BFDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Ball Bearing w/ Internal Air & WaterFDA Product Code EGS: Premium Slow Speed Contra-Angles 1:1 Fiber Optic Ball Bearing w/ Internal Air & WaterFDA Product Code EGS: Sable E-Type 1:1 Ball-Bearing Auto-Latch Contra-Angle P/N 1600214FDA Product Code EGS: Sable E-Type 1:1 Ball-Bearing PB FG Contra-Angle P/N 1600215FDA Product Code EGS: Sable E-Type 4:1 Auto-Latch Contra-Angle P/N 1600218FDA Product Code EGS: Sable E-Type 4:1 Screw-In Prophy Contra-Angle P/N 1600216FDA Product Code EGS: Sable E-Type 4:1 Snap-On Prophy Contra-Angle P/N 1600217FDA Product Code EGS: Sable EC Type 1:1 12-Tooth Contra-AngleFDA Product Code EGS: Sable Kavo Type 1:1 Contra-Angle w/ Internal A/WSable 4:1 Straight Attachments | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Sable Industries, Inc. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SABLE INDUSTRIES, INC.FDA reg. 3002105090 | Kitchener Ontario, Canada | Contract manufacturer, Manufacturer, Private-label distributor, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10024322). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.