510(k) · Cleared
ClearedDental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N
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 Nov 28, 2006 as substantially equivalent to K052822 (Thunder Tiger Corp., 2006) after a 70-day review. Its family tree reaches back 3 generations to 1995. 20 later devices descend from it.
- Decided
- Nov 28, 2006
- Review
- 70 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935676 (1995). 20 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 2 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 1 generation backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- This deviceK062812 Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B…Thunder Tiger Corp. · 2006
- Descendant · cites it directly · 13 of its ownK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
- Descendant · 2 generations on · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK170229 Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK113655 TI-Max X TurbineNakanishi, Inc. · 2012
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011 · cites it directly13descendants
- K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 2 generations on8descendants
- K170229Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 3 generations on4descendants
- K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · cites it directly3descendants
- K113655TI-Max X TurbineNakanishi, Inc. · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −2 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −1 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015 | — |
| +3 | K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
| +1 | K141886 | MDK Handpieces | Modern Korea Co., Ltd. | 2015 | — |
| +2 | K113655 | TI-Max X Turbine | Nakanishi, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Summary page 1…Model: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 510K No - K052822 Statement of Intended Use: The THUNDER TIGER DentalAir-PoweredHandpiece is intendedfor remo… | 2006 |
What descends from it? (20)
See all 204 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 11 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102517 (Thunder Tiger Corp., 2011) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K052822.
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 300T TIGER 300K, TIGER 300W TIGER 300B. TIGER 300N 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/K062812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062812: Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062812
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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