510(k) · Cleared
ClearedDental High-speed Handpiece and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microp Technology (Taiwan), Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Jul 24, 2018 as substantially equivalent to K130560 (Kaltenbach & Voigt GmbH, 2013) after a 210-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jul 24, 2018
- Review
- 210 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K992011 (1999). 10 ancestors in all, the oldest K863677 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK992011 Synea-HS High Speed-HandpieceA-Dec, Inc. · 1999
- 3 generations backK043498 Twin Power Turbine High Speed Air Turbine Dental HandpieceJ. Morita USA, Inc. · 2005
- 2 generations backK061701 High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power…J. Morita USA, Inc. · 2006
- 1 generation backK130560 Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013
- This deviceK173943 Dental High-speed Handpiece and AccessoriesMicrop Technology (Taiwan), Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K992011 | Synea-HS High Speed-Handpiece | A-Dec, Inc. | 1999 | — |
| −3 | K043498 | Twin Power Turbine High Speed Air Turbine Dental Handpiece | J. Morita USA, Inc. | 2005 | — |
| −2 | K061701 | High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H) | J. Morita USA, Inc. | 2006 | — |
| −1 | K130560 | Mastertorque Lux 8900 L | Kaltenbach & Voigt GmbH | 2013 | — |
| 0 (this device) | K173943 | Dental High-speed Handpiece and Accessories | Microp Technology (Taiwan), Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 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.
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 19 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 1 other device also cites its predicate K130560.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Dental High-speed Handpiece Halley Series is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173943: Dental High-speed Handpiece and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173943
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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