510(k) · Cleared
Recalled · Class II · 2012Lynx Low-Speed Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mti Precision Products · EFB Handpiece, Air-Powered, Dental
Cleared on Dec 29, 1994 after a 342-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 29, 1994
- Review
- 342 days
- Class
- Class I
- Product code
- EFB
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK940261 Lynx Low-Speed HandpieceMti Precision Products · 1994
- Descendant · cites it directly · 0 of its ownK070001 Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5…Mti Precision Products · 2007
Most influential descendants
Showing 1 of 1 · See all- K070001Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed Handpiece…Mti Precision Products · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940261 | Lynx Low-Speed Handpiece | Mti Precision Products | 1994 | — |
| +1 | K070001 | Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed… | Mti Precision Products | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K070001 | Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed Handpiece… | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2012 | Class II | Z-2044-2014 | Software design (manufacturing process) | Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070001 (Mti Precision Products, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
https://510kreport.com/device/K940261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940261: Lynx Low-Speed Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940261
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026