Manufacturer registered with FDA
Diaswiss, S. A.
Nyon, Switzerland. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 81,813 registrations outside the US
- Establishments
- 1Switzerland
Registered in 8 markets
Where regulators' registries name Diaswiss, S. A. 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 | Diaswiss, S. A. | 9 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Diaswiss SA | 1,797 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DIASWISS S. ADIASWISS S.A · DIASWISS S.A. | 6 | 2008–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Diaswiss SA | 3 | 2010–2010 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Diaswiss S.A | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | DIASWISS SA | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | DIASWISS S.A. | 2 | 2005–2015 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DIASWISS S.A | 1 | 2011–2011 | 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 Diaswiss, S. A. 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 | DRILL, DENTAL, INTRAORAL | 2017 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | INSTRUMENT, DIAMOND, DENTAL | 2017 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | DISK, ABRASIVE | 2017 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | POINT, ABRASIVE | 2017 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | BUR, DENTAL | 2000 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | WHEEL, POLISHING AGENT | 2017 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Lister | REAMER, PULP CANAL, ENDODONTIC | 2017 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | FILE, PULP CANAL, ENDODONTIC | 2017 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Lister | EKW / BROACH, ENDODONTIC | 2017 |
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 |
|---|---|---|
| DIASWISS S.A.FDA reg. 8031011 | NYON Vaud, Switzerland | Manufacturer, Private-label distributor |
Other names on FDA records
Diaswiss S.A.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8031011). 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.