Data / Medical devices / Switzerland / Thommen Medical, AG
Thommen Medical, AG: FDA-registered device maker in GRENCHEN Solothurn, Switzerland, 22 510(k) clearances
Thommen Medical, AG is registered with the FDA (registration 3003184527) in GRENCHEN Solothurn, Switzerland. It lists 4 device types. The FDA files 22 510(k) clearances under its listings, the newest dated September 29, 2017. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003184527
- Address
- Neckarsulmstrasse 28, GRENCHEN Solothurn, Switzerland, CH-2540
- Owner or operator
- THOMMEN MEDICAL, AG (9051144)
- Roles
- Manufacturer
- First device listed
- December 5, 2003
- Registered through
- 2026
- Brand names listed
- Implants PF6/L6.5, Milling Abutment for CAD/CAM, SPI ART, SPI ART Abutments, SPI Ceramic Vectodrills, SPI Contact PF 4, SPI Customizable Gingiva Former, SPI EASY PF4 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| September 29, 2017 | K171795 | Thommen Implant System | DZE | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| June 2, 2016 | K160244 | VARIOunite | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| March 10, 2016 | K151984 | Thommen Milling Abutment for CAD/CAM | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| August 14, 2012 | K121334 | VARIOECO | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| November 10, 2011 | K111984 | SPI VARIO ANGLED ABUTMENT | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| April 20, 2011 | K102804 | SPI TITANIUM BASE FOR CAD/CAM | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| August 19, 2010 | K101798 | SPI VARIOMULTI ANGLED ABUTMENT | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| March 4, 2010 | K093615 | SPI DENTAL IMPLANT, ELEMENT | DZE | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| September 25, 2009 | K092248 | SPI CUSTOMIZABLE GINGIVA FORMER | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| July 27, 2009 | K090154 | SPI DENTAL IMPLANT INICELL | DZE | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| March 27, 2009 | K090153 | SPI VARIOMULTI ANGLED ABUTMENT | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| February 15, 2008 | K072856 | SPI VARIOMULTI ABUTMENT | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| December 6, 2007 | K072649 | SPI SYSTEM DENTAL IMPLANTS | DZE | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| December 5, 2007 | K073141 | SPI ART ABUTMENT | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| November 15, 2007 | K072933 | SPI CONTACT PLATFORM O 4.0 MM | DZE | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| September 19, 2007 | K071453 | SPI EASY 4.0 ABUTMENT | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| April 17, 2007 | K070290 | SPI VECTODRILL CERAMIC DRILLS | NDP | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| January 10, 2007 | K070007 | SPI ELEMENT PLATFORM O 4.0 MM | DZE | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| July 31, 2006 | K061807 | SPI ART ABUTMENTS | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| July 28, 2005 | K051527 | SPI EASY TEMPORARY CAP | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| June 21, 2005 | K051502 | SPI DENTAL IMPLANT | DZE | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
| July 2, 2003 | K031747 | SPI DENTAL IMPLANT ABUTMENTS | NHA | Substantially Equivalent | Thommen Medical AG | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 24, 2024 | 94040 | Class II | Ongoing | impression coping, repositionable, short, screw-retained, PF 4.0 | The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant. | accessdata.fda.gov |
| April 3, 2019 | 82675 | Class II | Terminated | Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the pa | Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece). | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Handle, Instrument, Dental
Updated March 20, 2024. 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.