Thommen Medical AG
GRENCHEN Solothurn, CH
THOMMEN MEDICAL, AG appears in FDA device records in GRENCHEN Solothurn, CH. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Thommen Medical AG between 2002 and 2017. The busiest year on record is 2007, with 6. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 6 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171795 | Thommen Implant System | DZE | Substantially Equivalent | |
| K160244 | VARIOunite | NHA | Substantially Equivalent | |
| K151984 | Thommen Milling Abutment for CAD/CAM | NHA | Substantially Equivalent | |
| K121334 | VARIOECO | NHA | Substantially Equivalent | |
| K111984 | SPI VARIO ANGLED ABUTMENT | NHA | Substantially Equivalent | |
| K102804 | SPI TITANIUM BASE FOR CAD/CAM | NHA | Substantially Equivalent | |
| K101798 | SPI VARIOMULTI ANGLED ABUTMENT | NHA | Substantially Equivalent | |
| K093615 | SPI DENTAL IMPLANT, ELEMENT | DZE | Substantially Equivalent | |
| K092248 | SPI CUSTOMIZABLE GINGIVA FORMER | NHA | Substantially Equivalent | |
| K090154 | SPI DENTAL IMPLANT INICELL | DZE | Substantially Equivalent | |
| K090153 | SPI VARIOMULTI ANGLED ABUTMENT | NHA | Substantially Equivalent | |
| K072856 | SPI VARIOMULTI ABUTMENT | NHA | Substantially Equivalent | |
| K072649 | SPI SYSTEM DENTAL IMPLANTS | DZE | Substantially Equivalent | |
| K073141 | SPI ART ABUTMENT | NHA | Substantially Equivalent | |
| K072933 | SPI CONTACT PLATFORM O 4.0 MM | DZE | Substantially Equivalent | |
| K071453 | SPI EASY 4.0 ABUTMENT | NHA | Substantially Equivalent | |
| K070290 | SPI VECTODRILL CERAMIC DRILLS | NDP | Substantially Equivalent | |
| K070007 | SPI ELEMENT PLATFORM O 4.0 MM | DZE | Substantially Equivalent | |
| K061807 | SPI ART ABUTMENTS | NHA | Substantially Equivalent | |
| K051527 | SPI EASY TEMPORARY CAP | NHA | Substantially Equivalent | |
| K051502 | SPI DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K034014 | SPI CONTACT DENTAL IMPLANT | DZE | Substantially Equivalent | |
| K033346 | SPI EASY DENTAL IMPLANT PROTECTIVE CAP | NHA | Substantially Equivalent | |
| K031747 | SPI DENTAL IMPLANT ABUTMENTS | NHA | Substantially Equivalent | |
| K030689 | SPI ELEMENT DENTAL IMPLANT O 3.5 MM | DZE | Substantially Equivalent | |
| K023645 | SPI EASY DENTAL IMPLANT ABUTMENT | NHA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003184527 | 3003184527 | THOMMEN MEDICAL, AG | NECKARSULMSTRASSE 28, GRENCHEN Solothurn CH-2540 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1322-2024 | 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. | Class II | Open, Classified | |
| Z-1390-2019 | 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 packaging to the patient via a plug-in connection and screwed in manually or mechanically. | 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). | Class II | Terminated | |
| Z-1086-2007 | SPI EASY Abutment. Endosseous dental implant abutment. | The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain