510(k) · Cleared
ClearedOsstell Mentor Rfa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integration Diagnostics, Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Feb 26, 2004 as substantially equivalent to K003714 (Integration Diagnostics, Ltd., 2001) after a 94-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.
- Decided
- Feb 26, 2004
- Review
- 94 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003714 (2001). 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003714 Osstell Resonance Frequency AnalyzerIntegration Diagnostics, Ltd. · 2001
- This deviceK033689 Osstell Mentor RfaIntegration Diagnostics, Ltd. · 2004
- Descendant · cites it directly · 9 of its ownK082523 Osstell Isq Implant Stability MeterOsstell AB · 2008
- Descendant · 2 generations on · 3 of its ownK143445 Tellos ISQ BuddyTellos Medical AB · 2016
- Descendant · 2 generations on · 2 of its ownK181888 Osstell BeaconOsstell AB · 2019
- Descendant · 3 generations on · 1 of its ownK241065 ChecQ (AC100)Dentis Co., Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK180953 AnyCheck IMT-100Dms Co., Ltd. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K082523Osstell Isq Implant Stability MeterOsstell AB · 2008 · cites it directly9descendants
- K143445Tellos ISQ BuddyTellos Medical AB · 2016 · 2 generations on3descendants
- K181888Osstell BeaconOsstell AB · 2019 · 2 generations on2descendants
- K241065ChecQ (AC100)Dentis Co., Ltd. · 2025 · 3 generations on1descendant
- K180953AnyCheck IMT-100Dms Co., Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003714 | Osstell Resonance Frequency Analyzer | Integration Diagnostics, Ltd. | 2001 | — |
| 0 (this device) | K033689 | Osstell Mentor Rfa | Integration Diagnostics, Ltd. | 2004 | — |
| +1 | K082523 | Osstell Isq Implant Stability Meter | Osstell AB | 2008 | — |
| +2 | K143445 | Tellos ISQ Buddy | Tellos Medical AB | 2016 | — |
| +2 | K181888 | Osstell Beacon | Osstell AB | 2019 | — |
| +3 | K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025 | — |
| +2 | K180953 | AnyCheck IMT-100 | Dms Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003714 | Osstell Resonance Frequency AnalyzerSummary page 2…Number: §870.4200 Device Description: The Osstell Mentor Resonance Frequency Analyzer (RFA) is an updated version of the OsstellTM (K003714), the system designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K003714, the Oss… | 2001 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082523 | Osstell Isq Implant Stability Meter | 2008 | 9 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K082523 (Osstell AB, 2008) has gone furthest, with 9 descendants of its own.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033689: Osstell Mentor Rfa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033689
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026