Company ยท US
Thommen Medical AG
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2017. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2017 | K171795 | Thommen Implant System Thommen Medical AG, CH | DZE |
| Jun 2, 2016 | K160244 | VARIOunite Thommen Medical AG, CH | NHA |
| Mar 10, 2016 | K151984 | Thommen Milling Abutment for CAD/CAM Thommen Medical AG, CH | NHA |
| Aug 14, 2012 | K121334 | VARIOECO Thommen Medical AG | NHA |
| Nov 10, 2011 | K111984 | SPI VARIO ANGLED ABUTMENT Thommen Medical AG | NHA |
| Apr 20, 2011 | K102804 | SPI TITANIUM BASE FOR CAD/CAM Thommen Medical AG | NHA |
| Aug 19, 2010 | K101798 | SPI VARIOMULTI ANGLED ABUTMENT Thommen Medical AG | NHA |
| Mar 4, 2010 | K093615 | SPI DENTAL IMPLANT, ELEMENT Thommen Medical AG | DZE |
| Sep 25, 2009 | K092248 | SPI CUSTOMIZABLE GINGIVA FORMER Thommen Medical AG | NHA |
| Jul 27, 2009 | K090154 | SPI DENTAL IMPLANT INICELL Thommen Medical AG | DZE |
| Mar 27, 2009 | K090153 | SPI VARIOMULTI ANGLED ABUTMENT Thommen Medical AG | NHA |
| Feb 15, 2008 | K072856 | SPI VARIOMULTI ABUTMENT Thommen Medical AG | NHA |
| Dec 6, 2007 | K072649 | SPI SYSTEM DENTAL IMPLANTS Thommen Medical AG | DZE |
| Dec 5, 2007 | K073141 | SPI ART ABUTMENT Thommen Medical AG | NHA |
| Nov 15, 2007 | K072933 | SPI CONTACT PLATFORM O 4.0 MM Thommen Medical AG | DZE |
| Sep 19, 2007 | K071453 | SPI EASY 4.0 ABUTMENT Thommen Medical AG | NHA |
| Apr 17, 2007 | K070290 | SPI VECTODRILL CERAMIC DRILLS Thommen Medical AG | NDP |
| Jan 10, 2007 | K070007 | SPI ELEMENT PLATFORM O 4.0 MM Thommen Medical AG | DZE |
| Jul 31, 2006 | K061807 | SPI ART ABUTMENTS Thommen Medical AG | NHA |
| Jul 28, 2005 | K051527 | SPI EASY TEMPORARY CAP Thommen Medical AG | NHA |
| Jun 21, 2005 | K051502 | SPI DENTAL IMPLANT Thommen Medical AG | DZE |
| Mar 5, 2004 | K034014 | SPI CONTACT DENTAL IMPLANT Thommen Medical AG | DZE |
| Nov 3, 2003 | K033346 | SPI EASY DENTAL IMPLANT PROTECTIVE CAP Thommen Medical AG | NHA |
| Jul 2, 2003 | K031747 | SPI DENTAL IMPLANT ABUTMENTS Thommen Medical AG | NHA |
| Mar 26, 2003 | K030689 | SPI ELEMENT DENTAL IMPLANT O 3.5 MM Thommen Medical AG | DZE |
| Nov 13, 2002 | K023645 | SPI EASY DENTAL IMPLANT ABUTMENT Thommen Medical AG | NHA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2024 | Thommen Medical AG impression coping, repositionable, short, screw-retained, PF 4.0 Open, Classified |
NDP | None listed |
| Apr 3, 2019 | Thommen Medical AG 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 t Terminated |
NDP | None listed |
| Jul 24, 2007 | Thommen Medical, AG SPI EASY Abutment. Endosseous dental implant abutment. Terminated |
DZE | K023645 |