Thommen Medical AG: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Thommen Medical AG” (first 2002, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 103 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 180 |
| 2017 | 1 | 105 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Thommen Medical AG took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 16 | 16 |
| DZE | Implant, Endosseous, Root-Form | 9 | 9 |
| NDP | Accessories, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (26)
Most recent Thommen Medical AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171795 | Thommen Implant System | DZE | 2017-09-29 | 105 |
| K160244 | VARIOunite | NHA | 2016-06-02 | 122 |
| K151984 | Thommen Milling Abutment for CAD/CAM | NHA | 2016-03-10 | 237 |
| K121334 | VARIOECO | NHA | 2012-08-14 | 103 |
| K111984 | SPI VARIO ANGLED ABUTMENT | NHA | 2011-11-10 | 121 |
| K102804 | SPI TITANIUM BASE FOR CAD/CAM | NHA | 2011-04-20 | 205 |
| K101798 | SPI VARIOMULTI ANGLED ABUTMENT | NHA | 2010-08-19 | 52 |
| K093615 | SPI DENTAL IMPLANT, ELEMENT | DZE | 2010-03-04 | 101 |
| K092248 | SPI CUSTOMIZABLE GINGIVA FORMER | NHA | 2009-09-25 | 59 |
| K090154 | SPI DENTAL IMPLANT INICELL | DZE | 2009-07-27 | 186 |
16 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2024-01-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Thommen Medical AG?
FDA lists 26 510(k) clearances under the applicant name “Thommen Medical AG” (first 2002, latest 2017), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thommen Medical AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thommen Medical AG is 68 days.
Which FDA product codes appear under Thommen Medical AG?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 16); DZE (Implant, Endosseous, Root-Form, 9); NDP (Accessories, Implant, Dental, Endosseous, 1).
Next steps
- See all 26 Thommen Medical AG clearances with predicates and recalls
- Run predicate analysis for product code NHA, Thommen Medical AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.