Manufacturer registered with FDA
Thommen Medical AG
Grenchen, Switzerland. Lists 4 dental device types with FDA across 1 registered establishment, and holds 26 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 27
- 510(k) clearances
- 262002–2017
- Markets registered in
- 7172 registrations outside the US
- Establishments
- 1Switzerland
510(k) clearances per year, 2000–2026
Registered in 7 markets
Where regulators' registries name Thommen Medical 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 | Thommen Medical AG | 26 clearances | 2002–2017 | Below |
| Canada | Health Canada | Registration holder | THOMMEN MEDICAL AG | 84 | 2008–2017 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Thommen Medical AG | 52 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | THOMMEN MEDICAL AGThommen medical AG | 16 | 2005–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Thommen Medical AG | 7 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | THOMMEN MEDICAL AG | 7 | 2007–2017 | Pure Global AI |
| China | NMPA | Registration holder | 拓美医疗股份公司Thommen Medical AG | 6 | — | 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 Thommen Medical 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Milling Abutment for CAD/CAMSPI ARTSPI ART AbutmentsSPI Contact PF 4SPI Customizable Gingiva FormerSPI EASY PF4SPI EASY Temporary CapSPI ELEMENT PF4SPI Titanium Base CAD/CAMSPI VARIO angled abutment 5 moreSPI VARIO Multi AbutmentsSPI Vario Multi Angled AbutmentsSPI VARIO, SPI VARIO T, SPI Temporary, SPI EASY, SPI RETAINSPI VARIOmulti Angled 30°VARIOeco | 2007 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Implants PF6/L6.5SPI Contact PF 4SPI ELEMENTSPI ELEMENT INICELL, SPI CONTACT INICELLSPI ELEMENT PF4SPI ELEMENT, SPI CONTACT, SPI ONETIME, SPI DIRECTSPI INICELLSPI System Dental ImplantsSPI TST Implants | 2007 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | SPI Ceramic VectodrillsSPI Implant x-ray templatesSPI Implants, SPI Abutments | 2003 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Thommen Medical AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Sep 2017 | K171795 | Thommen Implant System | DZE Root-Form Endosseous Implant |
| 2 Jun 2016 | K160244 | VARIOunite | NHA Endosseous Dental Implant Abutment |
| 10 Mar 2016 | K151984 | Thommen Milling Abutment for CAD/CAM | NHA Endosseous Dental Implant Abutment |
| 14 Aug 2012 | K121334 | VARIOECO | NHA Endosseous Dental Implant Abutment |
| 10 Nov 2011 | K111984 | SPI VARIO ANGLED ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 20 Apr 2011 | K102804 | SPI TITANIUM BASE FOR CAD/CAM | NHA Endosseous Dental Implant Abutment |
| 19 Aug 2010 | K101798 | SPI VARIOMULTI ANGLED ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 4 Mar 2010 | K093615 | SPI DENTAL IMPLANT, ELEMENT | DZE Root-Form Endosseous Implant |
| 25 Sep 2009 | K092248 | SPI CUSTOMIZABLE GINGIVA FORMER | NHA Endosseous Dental Implant Abutment |
| 27 Jul 2009 | K090154 | SPI DENTAL IMPLANT INICELL | DZE Root-Form Endosseous Implant |
| 27 Mar 2009 | K090153 | SPI VARIOMULTI ANGLED ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 15 Feb 2008 | K072856 | SPI VARIOMULTI ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 6 Dec 2007 | K072649 | SPI SYSTEM DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 5 Dec 2007 | K073141 | SPI ART ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 15 Nov 2007 | K072933 | SPI CONTACT PLATFORM O 4.0 MM | DZE Root-Form Endosseous Implant |
| 19 Sep 2007 | K071453 | SPI EASY 4.0 ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 17 Apr 2007 | K070290 | SPI VECTODRILL CERAMIC DRILLS | NDP Endosseous Dental Implant Accessories |
| 10 Jan 2007 | K070007 | SPI ELEMENT PLATFORM O 4.0 MM | DZE Root-Form Endosseous Implant |
| 31 Jul 2006 | K061807 | SPI ART ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 28 Jul 2005 | K051527 | SPI EASY TEMPORARY CAP | NHA Endosseous Dental Implant Abutment |
| 21 Jun 2005 | K051502 | SPI DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 5 Mar 2004 | K034014 | SPI CONTACT DENTAL IMPLANT | DZE Root-Form Endosseous Implant |
| 3 Nov 2003 | K033346 | SPI EASY DENTAL IMPLANT PROTECTIVE CAP | NHA Endosseous Dental Implant Abutment |
| 2 Jul 2003 | K031747 | SPI DENTAL IMPLANT ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 26 Mar 2003 | K030689 | SPI ELEMENT DENTAL IMPLANT O 3.5 MM | DZE Root-Form Endosseous Implant |
| 13 Nov 2002 | K023645 | SPI EASY DENTAL IMPLANT ABUTMENT | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| THOMMEN MEDICAL, AGFDA reg. 3003184527 | GRENCHEN Solothurn, Switzerland | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9051144). 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.