510(k) · Cleared
ClearedStainless Turbine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Jun 21, 2022 as substantially equivalent to K131319 (Sirona Dental Systems GmbH, 2014) and 1 other predicate after a 540-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Jun 21, 2022
- Review
- 540 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935676 (1995). 24 ancestors in all, the oldest K760794 (1976). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 6 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 5 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 4 generations backK062812 Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B…Thunder Tiger Corp. · 2006
- 3 generations backK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
- 2 generations backK113655 TI-Max X TurbineNakanishi, Inc. · 2012
- 1 generation backK131319 T1/T2/T3 Turbine FamilySirona Dental Systems GmbH · 2014
- This deviceK203791 Stainless TurbineNakanishi, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230888 Titanium TurbineNakanishi, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230888Titanium TurbineNakanishi, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −6 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −5 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −4 | K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N | Thunder Tiger Corp. | 2006 | — |
| −3 | K102517 | Tiger 500 Series High Speed Handpieces and Attachments | Thunder Tiger Corp. | 2011 | — |
| −2 | K113655 | TI-Max X Turbine | Nakanishi, Inc. | 2012 | — |
| −1 | K131319 | T1/T2/T3 Turbine Family | Sirona Dental Systems GmbH | 2014 | — |
| 0 (this device) | K203791 | Stainless Turbine | Nakanishi, Inc. | 2022 | — |
| +1 | K230888 | Titanium Turbine | Nakanishi, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K131319 | T1/T2/T3 Turbine FamilySummary page 4…ndpiece and accessories Product Code: EFB Regulation: 872.4200 Primary Clearance: K131319 Predicate Device: Manufacturer: Sirona Dental Systems GmbH Trade Name: T1 / T2 / T3 T… | 2014 |
| * | K112024 | TI-Max X450Summary page 4…ndpiece and accessories Product Code: EFB Regulation: 872.4200 Secondary Clearance: K112024 Predicate Device: Manufacturer: NAKANISHI INC. Trade Name: Ti-Max X450… | 2012 |
| † | K980162 | Mach-Sigma Handpiece, Ultrapush | 1998 |
| † | K991701 | Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma MU (Mini Head), Mach-Sigma SU (STD.… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230888 | Titanium Turbine | 2023 | 0 |
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 27 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K230888 (Nakanishi, Inc., 2023) has gone furthest, with 0 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. 2022, 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 Stainless Turbine is intended for the following applications:
Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).
The coupling is intended for the following applications:
A connection device to transfer energy (air, water, light) required for handpieces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203791: Stainless Turbine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203791
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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