510(k) · Cleared
ClearedReusable SmartPeg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstell AB · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Sep 8, 2026 as substantially equivalent to K241065 (Dentis Co., Ltd., 2025) and 1 other predicate after an 88-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Sep 8, 2026
- Review
- 88 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003714 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK003714 Osstell Resonance Frequency AnalyzerIntegration Diagnostics, Ltd. · 2001
- 4 generations backK033689 Osstell Mentor RfaIntegration Diagnostics, Ltd. · 2004
- 3 generations backK082523 Osstell Isq Implant Stability MeterOsstell AB · 2008
- 2 generations backK143445 Tellos ISQ BuddyTellos Medical AB · 2016
- 1 generation backK241065 ChecQ (AC100)Dentis Co., Ltd. · 2025
- This deviceK261987 Reusable SmartPegOsstell AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003714 | Osstell Resonance Frequency Analyzer | Integration Diagnostics, Ltd. | 2001 | — |
| −4 | K033689 | Osstell Mentor Rfa | Integration Diagnostics, Ltd. | 2004 | — |
| −3 | K082523 | Osstell Isq Implant Stability Meter | Osstell AB | 2008 | — |
| −2 | K143445 | Tellos ISQ Buddy | Tellos Medical AB | 2016 | — |
| −1 | K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025 | — |
| 0 (this device) | K261987 | Reusable SmartPeg | Osstell AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 K241065 ChecQ (AC100)score 12.9 · 4 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 |
|---|---|---|---|
| * | K241065 | ChecQ (AC100)Summary page 5…ccessory Regulatory Class: Class 1 Regulation: 872.4200 Product Codes: EKX – handpiece, direct drive, ac-powered Primary Predicate Devices: K241065- ChecQ, K143445 Tellos ISQ Buddy Reference Devices: K181888- Osstell Beacon, K033689- Osstell Mentor Device Description: Th… | 2025 |
| * | K143445 | Tellos ISQ BuddySummary page 5…ory Class: Class 1 Regulation: 872.4200 Product Codes: EKX – handpiece, direct drive, ac-powered Primary Predicate Devices: K241065- ChecQ, K143445 Tellos ISQ Buddy Reference Devices: K181888- Osstell Beacon, K033689- Osstell Mentor Device Description: The reusable Smart… | 2016 |
| † | K181888 | Osstell Beacon | 2019 |
| † | K033689 | Osstell Mentor Rfa | 2004 |
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 25 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
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. 2026, 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?
Reusable SmartPeg is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261987 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261987: Reusable SmartPeg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261987
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026