# Osstell AB

- Location (FDA's records): Alexandria, VA
- FDA decisions: 5 (2008–2026): 5 510(k) clearances
- Product codes: EKX (5)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 6 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Integration Diagnostics, Ltd.: 1 (https://510kreport.com/company/integration-diagnostics)
- Dentis Co., Ltd.: 1 (https://510kreport.com/company/dentis)
- Tellos Medical AB: 1 (https://510kreport.com/company/tellos-medical)

## Firms that cite its devices most
- Dms Co., Ltd.: 1 (https://510kreport.com/company/dms)
- Tellos Medical AB: 1 (https://510kreport.com/company/tellos-medical)
- Dentis Co., Ltd.: 1 (https://510kreport.com/company/dentis)

## Its most-cited devices
- K082523: Osstell Isq Implant Stability Meter (2008), cited by 5
- K181888: Osstell Beacon (2019), cited by 1

## Recent decisions
- K261987: Reusable SmartPeg (Sep 8, 2026)
- K181888: Osstell Beacon (Aug 22, 2019)
- K142358: Osstell IDx (Feb 19, 2015)
- K132401: Mega Isq (Apr 9, 2014)
- K082523: Osstell Isq Implant Stability Meter (Sep 26, 2008)

Source page: https://510kreport.com/company/osstell