# K181888: Osstell Beacon

- Pathway: 510(k) (Traditional)
- Applicant: Osstell AB
- Decided: Aug 22, 2019 after 405 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003714 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082523: Osstell Isq Implant Stability Meter, Osstell AB (2008) Summary page 4.

## Most influential descendants
- K241065: ChecQ (AC100) (2025), 1 descendant of its own
- K261987: Reusable SmartPeg (2026), 0 descendants of its own

## Indications for use
Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

Source page: https://510kreport.com/device/K181888
Methodology: https://510kreport.com/methodology