Manufacturer registered with FDA
Sphinx Tools Ltd
Derendingen, Switzerland. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Switzerland
Devices listed with FDA
What Sphinx Tools 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 |
|---|---|---|---|---|
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | SYNTHES | 2017 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Fairfax | 2016 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | SYNTHES | 2017 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | FibreKor | 2008 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | CMF Medicon Surgical Inc | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SPHINX TOOLS LTDFDA reg. 9614438 | Derendingen Solothurn, Switzerland | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028077). 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.