Thommen Medical AG
FDA Regulatory Profile
Thommen Medical AG appears in FDA public data with 2 recalls, 26 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1322-2024, Class II) was initiated on January 24, 2024. Its most recent 510(k) clearance was granted on September 29, 2017.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 26
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1322-2024 | Class II | impression coping, repositionable, short, screw-retained, PF 4.0 | January 24, 2024 |
| Z-1390-2019 | Class II | Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Prod | April 3, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171795 | Thommen Implant System | September 29, 2017 |
| K160244 | VARIOunite | June 2, 2016 |
| K151984 | Thommen Milling Abutment for CAD/CAM | March 10, 2016 |
| K121334 | VARIOECO | August 14, 2012 |
| K111984 | SPI VARIO ANGLED ABUTMENT | November 10, 2011 |
| K102804 | SPI TITANIUM BASE FOR CAD/CAM | April 20, 2011 |
| K101798 | SPI VARIOMULTI ANGLED ABUTMENT | August 19, 2010 |
| K093615 | SPI DENTAL IMPLANT, ELEMENT | March 4, 2010 |
| K092248 | SPI CUSTOMIZABLE GINGIVA FORMER | September 25, 2009 |
| K090154 | SPI DENTAL IMPLANT INICELL | July 27, 2009 |
| K090153 | SPI VARIOMULTI ANGLED ABUTMENT | March 27, 2009 |
| K072856 | SPI VARIOMULTI ABUTMENT | February 15, 2008 |
| K072649 | SPI SYSTEM DENTAL IMPLANTS | December 6, 2007 |
| K073141 | SPI ART ABUTMENT | December 5, 2007 |
| K072933 | SPI CONTACT PLATFORM O 4.0 MM | November 15, 2007 |
| K071453 | SPI EASY 4.0 ABUTMENT | September 19, 2007 |
| K070290 | SPI VECTODRILL CERAMIC DRILLS | April 17, 2007 |
| K070007 | SPI ELEMENT PLATFORM O 4.0 MM | January 10, 2007 |
| K061807 | SPI ART ABUTMENTS | July 31, 2006 |
| K051527 | SPI EASY TEMPORARY CAP | July 28, 2005 |