510(k) · Cleared
ClearedChecQ (AC100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentis Co., Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Mar 21, 2025 as substantially equivalent to K181888 (Osstell AB, 2019) and 1 other predicate after a 337-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Mar 21, 2025
- Review
- 337 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003714 (2001). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK003714 Osstell Resonance Frequency AnalyzerIntegration Diagnostics, Ltd. · 2001
- 3 generations backK033689 Osstell Mentor RfaIntegration Diagnostics, Ltd. · 2004
- 2 generations backK082523 Osstell Isq Implant Stability MeterOsstell AB · 2008
- 1 generation backK143445 Tellos ISQ BuddyTellos Medical AB · 2016
- This deviceK241065 ChecQ (AC100)Dentis Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK261987 Reusable SmartPegOsstell AB · 2026
Most influential descendants
Showing 1 of 1 · See all- K261987Reusable SmartPegOsstell AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003714 | Osstell Resonance Frequency Analyzer | Integration Diagnostics, Ltd. | 2001 | — |
| −3 | K033689 | Osstell Mentor Rfa | Integration Diagnostics, Ltd. | 2004 | — |
| −2 | K082523 | Osstell Isq Implant Stability Meter | Osstell AB | 2008 | — |
| −1 | K143445 | Tellos ISQ Buddy | Tellos Medical AB | 2016 | — |
| 0 (this device) | K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025 | — |
| +1 | K261987 | Reusable SmartPeg | Osstell AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K181888 | Osstell BeaconSummary page 5…EKX Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K181888 Osstell Beacon EKX K143445 Tellos ISQ Buddy… | 2019 |
| * | K143445 | Tellos ISQ BuddySummary page 5…imary Predicate is listed first) Product Code K181888 Osstell Beacon EKX K143445 Tellos ISQ Buddy EKX Device Description Summary The Che… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261987 | Reusable SmartPeg | 2026 | 0 |
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K261987 (Osstell AB, 2026) has gone furthest, with 0 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. 2025, this device’s year, is highlighted.
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?
ChecQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241065: ChecQ (AC100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241065
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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