510(k) · Cleared
ClearedIS3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hiossen, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on May 16, 2018 as substantially equivalent to K143445 (Tellos Medical AB, 2016) after a 77-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 16, 2018
- Review
- 77 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003714 (2001). No later device cites it as a predicate yet.
- 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 deviceK180527 IS3Hiossen, Inc. · 2018
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) | K180527 | IS3 | Hiossen, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K143445 | Tellos ISQ BuddySummary page 4…ssification code : EKX Device class : Class I 3. Predicate Device Primary Predicate Device : Tellos ISQ Buddy ( K143445 ) Reference Predicate Device : Osstell ISQ ( K082523 ) 4. Device Description : 4.1. Description : IS3 measurement syste… | 2016 |
| † | K082523 | Osstell Isq Implant Stability Meter | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K143445.
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. 2018, 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?
IS3 is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180527: IS3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180527
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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