510(k) · Cleared
ClearedDental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202
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 Jan 20, 2006 as substantially equivalent to K033213 (Codent Technical Industry Co., Ltd., 2004) after a 108-day review. Its family tree reaches back 2 generations to 1995. 35 later devices descend from it.
- Decided
- Jan 20, 2006
- Review
- 108 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935676 (1995). 35 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 1 generation backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- This deviceK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- Descendant · cites it directly · 21 of its ownK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
- Descendant · cites it directly · 20 of its ownK062812 Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B…Thunder Tiger Corp. · 2006
- Descendant · 2 generations on · 17 of its ownK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
- Descendant · 3 generations on · 16 of its ownK112024 TI-Max X450Nakanishi, Inc. · 2012
- Descendant · 2 generations on · 13 of its ownK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K062740Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006 · cites it directly21descendants
- K062812Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300NThunder Tiger Corp. · 2006 · cites it directly20descendants
- K101717Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H…Aerobine, Inc. · 2010 · 2 generations on17descendants
- K112024TI-Max X450Nakanishi, Inc. · 2012 · 3 generations on16descendants
- K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −1 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| 0 (this device) | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| +1 | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | Jindell Medical Instruments Co., Ltd. | 2006 | — |
| +1 | K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N | Thunder Tiger Corp. | 2006 | — |
| +2 | K101717 | Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor… | Aerobine, Inc. | 2010 | — |
| +3 | K112024 | TI-Max X450 | Nakanishi, Inc. | 2012 | — |
| +2 | K102517 | Tiger 500 Series High Speed Handpieces and Attachments | Thunder Tiger Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K033213 | Codent Dental Air-Powered Handpiece, Model HPSSummary page 1…Panel: 72 · Predicate Device: CODENT DentalAir-PoweredHandpiece, model: HPS 510K No - K033213 Statement of Intended Use: The THUNDER TIGER Dental Air-PoweredHandpiece is intended./or removi… | 2004 |
What descends from it? (35)
See all 356 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | 2006 | 21 |
| K062812 | Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N | 2006 | 20 |
| K062947 | High Speed Air Turbine Handpiece, Models Super-Air and Super-QD Series | 2006 | 3 |
| K101551 | Pacemaker High-Speed Handpiece Model PM-MQ, PM-M | 2010 | 1 |
| K142063 | #8C Renegade Dental Handpiece | 2014 | 0 |
| K112623 | Airlight Dental Handpiece | 2011 | 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 11 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062740 (Jindell Medical Instruments Co., Ltd., 2006) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K033213.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
THUNDER TIGER Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
THUNDER TIGER Dental Air-Powered Handpiece carries the following label:
CAUTION. Federal (US) law restricts the use of this device to licensed professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052822: Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052822
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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