510(k) · Cleared
ClearedMaster Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed Handpiece and TM20 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 Feb 2, 2007 as substantially equivalent to K940261 (Mti Precision Products, 1994) after a 30-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Feb 2, 2007
- Review
- 30 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940261 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK940261 Lynx Low-Speed HandpieceMti Precision Products · 1994 · Recalled
- This deviceK070001 Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5…Mti Precision Products · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940261 | Lynx Low-Speed Handpiece | Mti Precision Products | 1994 | 1 |
| 0 (this device) | K070001 | Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed… | Mti Precision Products | 2007 | — |
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 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? (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 |
|---|---|---|---|
| * | K940261 | Lynx Low-Speed HandpieceSummary page 1…Powered, ~I CFR 8724200) Classification Product Co de~~ EFB Predicate Devices: Lynx Classic 51K Classic Air Motor K940261 Lynx TM5 - 5K Torquemaster K940261 Lynx TM2O - -2OK Torquemaste… | 1994 |
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?
- Its one ancestor has a recall.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as: Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece The following are examples for which the motors can be…
Read the full statement (150 words)
The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as:
Master Classic 5K Low Speed Handpiece
Master Classic 20K Low Speed Handpiece
Master TM5 5K Low Speed Handpiece
Master TM20 20K Low Speed Handpiece
The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used.
* Grinding and trimming on dentures and bridge work.
* Polishing and finishing of natural dentition
* Endodontic access procedures
* Cavity preparation
* Crown and cap preparation
* Post and pin setting
* Implant setting
The handpieces utilize materials known for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070001: Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed Handpiece and TM20 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/K070001
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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