Data / Medical devices / Sweden / Osstell AB
Osstell AB: FDA-registered device maker in GOTEBORG Vastra Gotaland, Sweden, 4 510(k) clearances
Osstell AB is registered with the FDA (registration 3004070020) in GOTEBORG Vastra Gotaland, Sweden. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 8, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004070020
- Address
- Stampgatan 14, GOTEBORG Vastra Gotaland, Sweden, 411 01
- Owner or operator
- OSSTELL AB (9059818)
- Roles
- Manufacturer
- First device listed
- April 10, 2014
- Registered through
- 2027
- Brand names listed
- Mega ISQ II, NeoTell, Osstell Beacon, Osstell Classic, OsstellConnect, Smart Pegs Type 1-111, SmartPeg Type 004R, SmartPeg Type 005R and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | K261987 | Reusable SmartPeg | EKX | Substantially Equivalent | Osstell AB | accessdata.fda.gov |
| August 22, 2019 | K181888 | Osstell Beacon | EKX | Substantially Equivalent | Osstell AB | accessdata.fda.gov |
| February 19, 2015 | K142358 | Osstell IDx | EKX | Substantially Equivalent | Osstell AB | accessdata.fda.gov |
| April 9, 2014 | K132401 | MEGA ISQ | EKX | Substantially Equivalent | Osstell AB | accessdata.fda.gov |
Compare with other makers
Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.