# K261987: Reusable SmartPeg

- Pathway: 510(k) (Traditional)
- Applicant: Osstell AB
- Decided: Sep 8, 2026 after 88 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: 5 generations back to K003714 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241065: ChecQ (AC100), Dentis Co., Ltd. (2025) Summary page 5.
- K143445: Tellos ISQ Buddy, Tellos Medical AB (2016) Summary page 5.

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

Source page: https://510kreport.com/device/K261987
Methodology: https://510kreport.com/methodology