# K033689: Osstell Mentor Rfa

- Pathway: 510(k) (Traditional)
- Applicant: Integration Diagnostics, Ltd.
- Decided: Feb 26, 2004 after 94 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: 1 generation back to K003714 (2001). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003714: Osstell Resonance Frequency Analyzer, Integration Diagnostics, Ltd. (2001) Summary page 2.

## Most influential descendants
- K082523: Osstell Isq Implant Stability Meter (2008), 9 descendants of its own
- K143445: Tellos ISQ Buddy (2016), 3 descendants of its own
- K181888: Osstell Beacon (2019), 2 descendants of its own
- K241065: ChecQ (AC100) (2025), 1 descendant of its own
- K180953: AnyCheck IMT-100 (2019), 1 descendant of its own

## Indications for use
The Osstell Mentor is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. The Osstell Mentor can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.

Source page: https://510kreport.com/device/K033689
Methodology: https://510kreport.com/methodology