Manufacturer registered with FDA
Jota AG
Ruethi, Switzerland. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 540 registrations outside the US
- Establishments
- 1Switzerland
Registered in 5 markets
Where regulators' registries name Jota AG 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 | Jota AG | 7 device types | — | Below |
| Taiwan | TFDA | Manufacturer | JOTA AG | 17 | 2006–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | JOTA AGJOTA AG. | 11 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JOTA AG | 7 | 2011–2016 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | JOTA AG | 5 | 2023–2026 | 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 Jota AG 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 | JOTA | 2003 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | JOTA | 2003 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | JOTA | 2003 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | JOTA | 2003 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | JOTA | 2003 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | JOTA | 2003 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | JOTA | 2003 |
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 |
|---|---|---|
| JOTA AGFDA reg. 8031050 | RUETHI, SG Sankt Gallen, Switzerland | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8031050). 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.