# K180527: IS3

- Pathway: 510(k) (Traditional)
- Applicant: Hiossen, Inc.
- Decided: May 16, 2018 after 77 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: 4 generations back to K003714 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143445: Tellos ISQ Buddy, Tellos Medical AB (2016) Summary page 4.

## Indications for use
IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.

Source page: https://510kreport.com/device/K180527
Methodology: https://510kreport.com/methodology