510(k) · Cleared
ClearedJindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jindell Medical Instruments Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Nov 2, 2006 as substantially equivalent to K052822 (Thunder Tiger Corp., 2006) after a 50-day review. Its family tree reaches back 3 generations to 1995. 21 later devices descend from it.
- Decided
- Nov 2, 2006
- Review
- 50 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935676 (1995). 21 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 deviceK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
- Descendant · cites it directly · 17 of its ownK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
- Descendant · 2 generations on · 16 of its ownK112024 TI-Max X450Nakanishi, Inc. · 2012
- Descendant · 3 generations on · 9 of its ownK130455 430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013
- Descendant · 4 generations on · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
- Descendant · 5 generations on · 4 of its ownK170229 Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K101717Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H…Aerobine, Inc. · 2010 · cites it directly17descendants
- K112024TI-Max X450Nakanishi, Inc. · 2012 · 2 generations on16descendants
- K130455430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013 · 3 generations on9descendants
- K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 4 generations on8descendants
- K170229Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 5 generations on4descendants
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) | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | Jindell Medical Instruments Co., Ltd. | 2006 | — |
| +1 | K101717 | Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor… | Aerobine, Inc. | 2010 | — |
| +2 | K112024 | TI-Max X450 | Nakanishi, Inc. | 2012 | — |
| +3 | K130455 | 430 SWL 45 and 430 SW 45 High-Speed Handpieces | Dentalez Group, Stardental Division | 2013 | — |
| +4 | K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015 | — |
| +5 | K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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? (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…models: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 510K No -K052822 * Statement of Intended Use: The JINDELL High Speed Air Turbine Handpieces are intended for removing c… | 2006 |
What descends from it? (21)
See all 214 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 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101717 (Aerobine, Inc., 2010) has gone furthest, with 17 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?
JINDELL High Speed Air Turbine Handpiece, models: SW, SP SU, ETU, MU are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
JINDELL High Speed Air Turbine 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/K062740 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062740: Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062740
Report an extraction error
Are you the manufacturer?
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