Data / Medical devices / Switzerland / SPT Roth Ltd.
SPT Roth Ltd.: FDA-registered device maker in LYSS Bern, Switzerland, 1 510(k) clearance
SPT Roth Ltd. is registered with the FDA (registration 9616044) in LYSS Bern, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 19, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616044
- FEI number
- 3002336796
- Address
- Werkstrasse 28, LYSS Bern, Switzerland, 3250
- Owner or operator
- SPT ROTH LTD. (9043481)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 5, 2011
- Registered through
- 2026
- Brand names listed
- Clarity Advanced Ceramic Brackets, Clarity SL, ceramic, orthodontic bracket
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Ceramic, Orthodontic | NJM | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 19, 2011 | K110335 | CERAMIC BRACKETS | NJM | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 19, 2011. 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.