Data / Medical devices / Canada / Sable Industries, Inc.
Sable Industries, Inc.: FDA-registered device maker in Kitchener Ontario, Canada, 2 510(k) clearances
Sable Industries, Inc. is registered with the FDA (registration 3002105090) in Kitchener Ontario, Canada. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 23, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002105090
- Address
- 100 Campbell Avenue, Suite 5, Kitchener Ontario, Canada, N2H 4X8
- Owner or operator
- Sable Industries, Inc. (10024322)
- Roles
- Contract manufacturer, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 21, 2008
- Registered through
- 2026
- Brand names listed
- 4 Hole 360 degree Quick-Connect or Multiflex(TM) Couplers, Access II, Access K4, Access K6, Access KL, Access L, Access Pro KL - 2000020, Access Pro KL Kavo Interchangeable Fiber Optic Mini Head P/N 2000021 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | Contract manufacturer, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Unit, Suction Operatory | EBR | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2009 | K083101 | PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES | EFB | Substantially Equivalent | Sable Industries, Inc. | accessdata.fda.gov |
| November 14, 2007 | K072554 | ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES | EFB | Substantially Equivalent | Sable Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Handpiece, Air-Powered, Dental
- All makers of Unit, Suction Operatory
- All makers of Unit, Syringe, Air And/Or Water
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated February 23, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.