Manufacturer registered with FDA
Fairfax MEDICAL PRODUCTS Ltd
London, United Kingdom. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 314 registrations outside the US
- Establishments
- 1United Kingdom
Registered in 3 markets
Where regulators' registries name Fairfax MEDICAL PRODUCTS Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Fairfax MEDICAL PRODUCTS Ltd | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Fairfax Medical Products Limited | 12 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Fairfax Medical Products Ltd | 2 | — | 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 Fairfax MEDICAL PRODUCTS Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Stabilok drill | 2018 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Stabident | 2011 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Stabilok | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Fairfax MEDICAL PRODUCTS Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Fairfax Dental, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Jun 1991 | K910446 | STABIDENT LOCAL ANESTHESIA SYSTEM | Fairfax Dental, Inc. | DZM Dental Needle |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FAIRFAX MEDICAL PRODUCTS LtdFDA reg. 3004139812 | London London, City of, United Kingdom | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035045). 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.