510(k) · Cleared
ClearedTellos ISQ Buddy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tellos Medical AB · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Jan 7, 2016 as substantially equivalent to K082523 (Osstell AB, 2008) after a 401-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Jan 7, 2016
- Review
- 401 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003714 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK003714 Osstell Resonance Frequency AnalyzerIntegration Diagnostics, Ltd. · 2001
- 2 generations backK033689 Osstell Mentor RfaIntegration Diagnostics, Ltd. · 2004
- 1 generation backK082523 Osstell Isq Implant Stability MeterOsstell AB · 2008
- This deviceK143445 Tellos ISQ BuddyTellos Medical AB · 2016
- Descendant · cites it directly · 1 of its ownK241065 ChecQ (AC100)Dentis Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK261987 Reusable SmartPegOsstell AB · 2026
- Descendant · cites it directly · 0 of its ownK180527 IS3Hiossen, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003714 | Osstell Resonance Frequency Analyzer | Integration Diagnostics, Ltd. | 2001 | — |
| −2 | K033689 | Osstell Mentor Rfa | Integration Diagnostics, Ltd. | 2004 | — |
| −1 | K082523 | Osstell Isq Implant Stability Meter | Osstell AB | 2008 | — |
| 0 (this device) | K143445 | Tellos ISQ Buddy | Tellos Medical AB | 2016 | — |
| +1 | K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025 | — |
| +1 | K261987 | Reusable SmartPeg | Osstell AB | 2026 | — |
| +1 | K180527 | IS3 | Hiossen, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K082523 | Osstell Isq Implant Stability MeterSummary page 4…SmartPeg Predicate Device 510(k) information: Device Classification Name Handpiece, Direct Drive, AC-Powered 510(k) Number K082523 Device Name OSSTELL ISQ IMPLANT STABILITY METER Regulation Number 872.420… | 2008 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K241065 (Dentis Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K082523.
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. 2016, 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?
Tellos ISQ Buddy is indicated for use in measuring the stability of dental implants in the oral cavity and the 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/K143445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143445: Tellos ISQ Buddy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143445
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