Osstell AB: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Osstell AB” (first 2008, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 178 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 251 |
| 2015 | 1 | 178 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 405 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 88 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Osstell AB took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 266 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | 5 | 5 |
Review panels
- Dental (5)
Most recent Osstell AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261987 | Reusable SmartPeg | EKX | 2026-09-08 | 88 |
| K181888 | Osstell Beacon | EKX | 2019-08-22 | 405 |
| K142358 | Osstell IDx | EKX | 2015-02-19 | 178 |
| K132401 | MEGA ISQ | EKX | 2014-04-09 | 251 |
| K082523 | OSSTELL ISQ IMPLANT STABILITY METER | EKX | 2008-09-26 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Osstell AB.
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 Osstell AB?
FDA lists 5 510(k) clearances under the applicant name “Osstell AB” (first 2008, latest 2026), across 1 product code 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 Osstell AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Osstell AB is 178 days.
Which FDA product codes appear under Osstell AB?
The most frequent FDA product codes under this applicant name are EKX (Handpiece, Direct Drive, Ac-Powered, 5).
Next steps
- See all 5 Osstell AB clearances with predicates and recalls
- Run predicate analysis for product code EKX, Osstell AB'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.