510(k) · Cleared
ClearedTwin Power Turbine High Speed Air Turbine Dental Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Feb 16, 2005 as substantially equivalent to K992011 (A-Dec, Inc., 1999) after a 61-day review. Its family tree reaches back 1 generation to 1999. 11 later devices descend from it.
- Decided
- Feb 16, 2005
- Review
- 61 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992011 (1999). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992011 Synea-HS High Speed-HandpieceA-Dec, Inc. · 1999
- This deviceK043498 Twin Power Turbine High Speed Air Turbine Dental HandpieceJ. Morita USA, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK061701 High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power…J. Morita USA, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK130560 Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013
- Descendant · 3 generations on · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK131319 T1/T2/T3 Turbine FamilySirona Dental Systems GmbH · 2014
- Descendant · 2 generations on · 1 of its ownK203791 Stainless TurbineNakanishi, Inc. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K061701High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)J. Morita USA, Inc. · 2006 · cites it directly7descendants
- K130560Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013 · 2 generations on5descendants
- K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · 3 generations on3descendants
- K131319T1/T2/T3 Turbine FamilySirona Dental Systems GmbH · 2014 · cites it directly2descendants
- K203791Stainless TurbineNakanishi, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992011 | Synea-HS High Speed-Handpiece | A-Dec, Inc. | 1999 | — |
| 0 (this device) | K043498 | Twin Power Turbine High Speed Air Turbine Dental Handpiece | J. Morita USA, Inc. | 2005 | — |
| +1 | K061701 | High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H) | J. Morita USA, Inc. | 2006 | — |
| +2 | K130560 | Mastertorque Lux 8900 L | Kaltenbach & Voigt GmbH | 2013 | — |
| +3 | K141886 | MDK Handpieces | Modern Korea Co., Ltd. | 2015 | — |
| +1 | K131319 | T1/T2/T3 Turbine Family | Sirona Dental Systems GmbH | 2014 | — |
| +2 | K203791 | Stainless Turbine | Nakanishi, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992011 | Synea-HS High Speed-Handpiece | 1999 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 no recall.
- Of its descendants, K061701 (J. Morita USA, Inc., 2006) has gone furthest, with 7 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 | — |
What is it indicated for?
The TWIN POWER TURBINE handpiece is for use by authorized persons in the
practice of dentistry
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043498 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043498: Twin Power Turbine High Speed Air Turbine Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043498
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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