510(k) · Cleared
ClearedTiger 500 Series High Speed Handpieces and Attachments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thunder Tiger Corp. · EFB Handpiece, Air-Powered, Dental
Cleared on Apr 27, 2011 as substantially equivalent to K062812 (Thunder Tiger Corp., 2006) and 3 other predicates after a 237-day review. Its family tree reaches back 4 generations to 1995. 13 later devices descend from it.
- Decided
- Apr 27, 2011
- Review
- 237 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K935676 (1995). 11 ancestors in all, the oldest K863677 (1986). 13 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 3 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 2 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 1 generation backK062812 Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B…Thunder Tiger Corp. · 2006
- This deviceK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
- Descendant · cites it directly · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK170229 Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK113655 TI-Max X TurbineNakanishi, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK131319 T1/T2/T3 Turbine FamilySirona Dental Systems GmbH · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · cites it directly8descendants
- K170229Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 2 generations on4descendants
- K113655TI-Max X TurbineNakanishi, Inc. · 2012 · cites it directly3descendants
- K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · 3 generations on2descendants
- K131319T1/T2/T3 Turbine FamilySirona Dental Systems GmbH · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −3 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −2 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −1 | K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N | Thunder Tiger Corp. | 2006 | — |
| 0 (this device) | K102517 | Tiger 500 Series High Speed Handpieces and Attachments | Thunder Tiger Corp. | 2011 | — |
| +1 | K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015 | — |
| +2 | K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
| +1 | K113655 | TI-Max X Turbine | Nakanishi, Inc. | 2012 | — |
| +3 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | 2020 | — |
| +2 | K131319 | T1/T2/T3 Turbine Family | Sirona Dental Systems GmbH | 2014 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300NSummary page 1…Product Code EFB) 4. Predicate Device: Dental Air-Powered Handpiece, models TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N (K0628 12) SUPERtorque High-Speed Handpieces (K073478) ________ Tradition… | 2006 |
| * | K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSummary page 1…TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N (K0628 12) SUPERtorque High-Speed Handpieces (K073478) ________ Tradition high speed Handpiece_(K863677) ____ ______… | 2008 |
| * | K863677 | Tradition High Speed HandpieceSummary page 1…GER 300N (K0628 12) SUPERtorque High-Speed Handpieces (K073478) ________ Tradition high speed Handpiece_(K863677) ____ ______ Rapidd high speed Handpiece (K0035 18) 5. Device Descripti… | 1986 |
| * | K003518 | Rapidd Highspeed Dental HandpieceSummary page 1…________ Tradition high speed Handpiece_(K863677) ____ ______ Rapidd high speed Handpiece (K0035 18) 5. Device Description: The Tiger 500 series High Speed Handpieces and Attachments are similar to other… | 2001 |
What descends from it? (13)
See all 132 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 16 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K152146 (Codent Technical Industry Co., Ltd., 2015) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K062812.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Tiger 500 Series High Speed Handpieces and Attachments are 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/K102517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102517: Tiger 500 Series High Speed Handpieces and Attachments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102517
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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