510(k) · Cleared
ClearedDisposable High Speed Air Turbine Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Hpdove Dental Instruments Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Aug 11, 2020 as substantially equivalent to K152146 (Codent Technical Industry Co., Ltd., 2015) after a 259-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Aug 11, 2020
- Review
- 259 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K935676 (1995). 24 ancestors in all, the oldest K760794 (1976). No later device cites it as a predicate yet.
- Root · 8 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 7 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 6 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 5 generations backK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
- 4 generations backK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
- 3 generations backK112024 TI-Max X450Nakanishi, Inc. · 2012
- 2 generations backK130455 430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013
- 1 generation backK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
- This deviceK193264 Disposable High Speed Air Turbine HandpieceNingbo Hpdove Dental Instruments Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −7 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −6 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −5 | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | Jindell Medical Instruments Co., Ltd. | 2006 | — |
| −4 | 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 | K130455 | 430 SWL 45 and 430 SW 45 High-Speed Handpieces | Dentalez Group, Stardental Division | 2013 | — |
| −1 | K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015 | — |
| 0 (this device) | K193264 | Disposable High Speed Air Turbine Handpiece | Ningbo Hpdove Dental Instruments Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K152146 | High Speed Handpieces and AccessoriesSummary page 5…andpiece Classification : 21CFR872.4200 Predicate Device: Trade Name: High-Speed Handpieces and Accessories 510(k) Reference: K152146 Common Name: Handpiece, air-powered, dental Regulation Number: 21CFR872.4200 Regulatory… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 24 ancestors has a recall of any class.
- 3 other devices also cite its predicate K152146.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Disposable high speed air turbine handpiece is intended for removing carious material, excess filling material, cavity and
crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193264: Disposable High Speed Air Turbine Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193264
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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