Manufacturer registered with FDA
SPT Roth Ltd.
Lyss, Switzerland. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1Switzerland
Registered in 2 markets
Where regulators' registries name SPT Roth 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 | SPT Roth Ltd. | 1 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | SPT ROTH 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 SPT Roth 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 |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | ceramic, orthodontic bracketClarity Advanced Ceramic BracketsClarity SL | 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
SPT Roth 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: Ortho Organizers, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 May 2011 | K110335 | CERAMIC BRACKETS | Ortho Organizers, Inc. | NJM Orthodontic Ceramic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SPT ROTH LTD.FDA reg. 9616044 | LYSS Bern, Switzerland | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9043481). 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.