510(k) · Cleared
ClearedHigh Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EFA Handpiece, Belt And/Or Gear Driven, Dental
Cleared on Aug 25, 2006 as substantially equivalent to K043498 (J. Morita USA, Inc., 2005) after a 70-day review. Its family tree reaches back 2 generations to 1999. 7 later devices descend from it.
- Decided
- Aug 25, 2006
- Review
- 70 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992011 (1999). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK992011 Synea-HS High Speed-HandpieceA-Dec, Inc. · 1999
- 1 generation backK043498 Twin Power Turbine High Speed Air Turbine Dental HandpieceJ. Morita USA, Inc. · 2005
- This deviceK061701 High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power…J. Morita USA, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK130560 Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013
- Descendant · 2 generations on · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK202786 Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K130560Mastertorque Lux 8900 LKaltenbach & Voigt GmbH · 2013 · cites it directly5descendants
- K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · 2 generations on3descendants
- K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · 3 generations on0descendants
- K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · 3 generations on0descendants
- K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992011 | Synea-HS High Speed-Handpiece | A-Dec, Inc. | 1999 | — |
| −1 | K043498 | Twin Power Turbine High Speed Air Turbine Dental Handpiece | J. Morita USA, Inc. | 2005 | — |
| 0 (this device) | 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 | — |
| +2 | K141886 | MDK Handpieces | Modern Korea Co., Ltd. | 2015 | — |
| +3 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | 2026 | — |
| +3 | K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS… | Foshan Topmed Dental Co., Ltd. | 2026 | — |
| +3 | K202786 | Dental Low-speed Handpieces and Accessories | Microp Technology (Taiwan), Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 EFA? 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 EFA device
- #1 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K043498 | Twin Power Turbine High Speed Air Turbine Dental HandpieceSummary page 1…) 5. Substantial Equivalency is claimed against tIlie following device: PAR-4HE-O of J. MORITA MFG. CORP.( K043498) .13 6. Description of the device: VII-1 DEVICE DESCRI… | 2005 |
What descends from it? (7)
2 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130560 (Kaltenbach & Voigt GmbH, 2013) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K043498.
How does its category compare?
All EFA devicesEFA Handpiece, Belt And/Or Gear Driven, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EFA
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFA
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFA
4in 2025
MAUDE reports naming product code EFA, 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 | 1 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 4 | 78 | 0 | 0 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PAR-4HEX/4HX series handpiece is for use by authorized persons in the practice of the dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061701 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061701: High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061701
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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