510(k) · Cleared
ClearedTI-Max X 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 Mar 5, 2012 as substantially equivalent to K102517 (Thunder Tiger Corp., 2011) after an 84-day review. Its family tree reaches back 5 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 5, 2012
- Review
- 84 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935676 (1995). 12 ancestors in all, the oldest K863677 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 4 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 3 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 2 generations backK062812 Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B…Thunder Tiger Corp. · 2006
- 1 generation backK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
- This deviceK113655 TI-Max X TurbineNakanishi, Inc. · 2012
- 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
- Descendant · 3 generations on · 0 of its ownK230888 Titanium TurbineNakanishi, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −4 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −3 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −2 | K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N | Thunder Tiger Corp. | 2006 | — |
| −1 | K102517 | Tiger 500 Series High Speed Handpieces and Attachments | Thunder Tiger Corp. | 2011 | — |
| 0 (this device) | K113655 | TI-Max X Turbine | Nakanishi, Inc. | 2012 | — |
| +1 | K131319 | T1/T2/T3 Turbine Family | Sirona Dental Systems GmbH | 2014 | — |
| +2 | K203791 | Stainless Turbine | Nakanishi, Inc. | 2022 | — |
| +3 | K230888 | Titanium Turbine | Nakanishi, Inc. | 2023 | — |
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 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K102517 | Tiger 500 Series High Speed Handpieces and AttachmentsSummary page 1…h Speed Air Turbine Handpiece Classification Name: 872.4200 EFB3 Handpiece, Mir-Powered, Dental Predicate Device: K102517 - Thunder Tiger, Inc., Tiger 500 Series High Speed Handpieces and Attachmen… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131319 | T1/T2/T3 Turbine Family | 2014 | 2 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K131319 (Sirona Dental Systems GmbH, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K102517.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Ti-Max X Turbine Series is an air-powered dental handpiece intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113655: TI-Max X Turbine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113655
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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