510(k) · Cleared
ClearedE-Type Speed Reducer Contra Angle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nsk Nakanishi, Inc. · KMW Handpiece, Rotary Bone Cutting
Cleared on Apr 15, 1997 after a 29-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Apr 15, 1997
- Review
- 29 days
- Class
- Class II
- Product code
- KMW
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK970953 E-Type Speed Reducer Contra AngleNsk Nakanishi, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK092214 Chiropro L SystemBien-Air Dental, SA · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK140308 Mastersurg / ExpertsurgKaltenbach & Voigt GmbH · 2014
- Descendant · 3 generations on · 0 of its ownK213139 SURGmatic S15 L ProKavo Dental GmbH · 2021
- Descendant · 3 generations on · 0 of its ownK193341 iCTmotor (WL-1)Dentium Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK171155 Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092214Chiropro L SystemBien-Air Dental, SA · 2009 · cites it directly4descendants
- K140308Mastersurg / ExpertsurgKaltenbach & Voigt GmbH · 2014 · 2 generations on2descendants
- K213139SURGmatic S15 L ProKavo Dental GmbH · 2021 · 3 generations on0descendants
- K193341iCTmotor (WL-1)Dentium Co., Ltd. · 2020 · 3 generations on0descendants
- K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970953 | E-Type Speed Reducer Contra Angle | Nsk Nakanishi, Inc. | 1997 | — |
| +1 | K092214 | Chiropro L System | Bien-Air Dental, SA | 2009 | 1 |
| +2 | K140308 | Mastersurg / Expertsurg | Kaltenbach & Voigt GmbH | 2014 | — |
| +3 | K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | 2021 | — |
| +3 | K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | 2020 | — |
| +1 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017 | 8 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 KMW? 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 KMW device
- #1 K211584 Oral Surgery Contrascore 2.8 · 4 generations · no Class I recall
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? (6)
3 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?
- Of its descendants, K092214 (Bien-Air Dental, SA, 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KMW devicesKMW Handpiece, Rotary Bone Cutting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMW
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KMW
Too few KMW 510(k)s in any year since 2007 to give a median.
Recalls per year · KMW
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMW
22in 2025
MAUDE reports naming product code KMW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 0 | — | 8 | 16 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 1 | 32 |
| 2022 | 0 | — | 0 | 54 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970953: E-Type Speed Reducer Contra Angle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970953
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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