510(k) · Cleared
ClearedHigh Speed Handpieces and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codent Technical Industry Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Dec 8, 2015 as substantially equivalent to K033213 (Codent Technical Industry Co., Ltd., 2004) and 3 other predicates after a 127-day review. Its family tree reaches back 7 generations to 1995. 8 later devices descend from it.
- Decided
- Dec 8, 2015
- Review
- 127 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K935676 (1995). 23 ancestors in all, the oldest K760794 (1976). 8 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 6 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 5 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 4 generations backK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
- 3 generations backK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
- 2 generations backK112024 TI-Max X450Nakanishi, Inc. · 2012
- 1 generation backK130455 430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013
- This deviceK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
- Descendant · cites it directly · 4 of its ownK170229 Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK220179 High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…Foshan Coxo Medical Instrument Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK251389 High speed air turbine handpieceFoshan Topmed Dental Co., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK241074 High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19…Foshan Soco Precision Instrument Co., Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K170229Dental High-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · cites it directly4descendants
- K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · 2 generations on2descendants
- K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2023 · 3 generations on1descendant
- K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd. · 2026 · 2 generations on0descendants
- K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…Foshan Soco Precision Instrument Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −6 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −5 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −4 | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | Jindell Medical Instruments Co., Ltd. | 2006 | — |
| −3 | K101717 | Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor… | Aerobine, Inc. | 2010 | — |
| −2 | K112024 | TI-Max X450 | Nakanishi, Inc. | 2012 | — |
| −1 | K130455 | 430 SWL 45 and 430 SW 45 High-Speed Handpieces | Dentalez Group, Stardental Division | 2013 | — |
| 0 (this device) | K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015 | — |
| +1 | K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
| +2 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | 2020 | — |
| +3 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle… | Foshan Coxo Medical Instrument Co., Ltd. | 2023 | — |
| +2 | K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | 2026 | — |
| +4 | K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22)… | Foshan Soco Precision Instrument Co., Ltd. | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K033213 | Codent Dental Air-Powered Handpiece, Model HPSSummary page 4…MODEL HPS Manufacturer: Codent Technical Industry Co., Ltd. Product Code: EFB 510(k) Number: K033213 Concurrence date February, 06, 2004 6- 1 CODENT… | 2004 |
| * | K130455 | 430 SWL 45 and 430 SW 45 High-Speed HandpiecesSummary page 5…HANDPIECES Manufacturer: DENTALEZ GROUP, STARDENTAL DIVISION Product Code: EFB 510(k) Number: K130455 Concurrence date September, 25, 2013 Reference Predicate Predicate Device Name: W&H ROTO QUICK… | 2013 |
| * | K945734 | W&H Roto Quick CouplingsSummary page 5…evice Name: W&H ROTO QUICK COUPLING Manufacturer: A-DEC, INC. Product Code: EFB 510(k) Number: K945734 Concurrence date October, 05, 1995 Reference Predicate Predicate Device Name: TIGER 500 SERIES… | 1995 |
| * | K102517 | Tiger 500 Series High Speed Handpieces and AttachmentsSummary page 5…ATTACHMENTS Manufacturer: THUNDER TIGER CORP. Product Code: EFB 510(k) Number: K102517 Concurrence date April, 27, 2011 6-6 Intended Use and Indications for Use of the Subject Device: High S… | 2011 |
What descends from it? (8)
4 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 20 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K170229 (Guangdong Jinme Medical Technology Co., Ltd., 2017) has gone furthest, with 4 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. 2015, 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?
High Speed Handpieces and Accessories are 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/K152146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152146: High Speed Handpieces and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152146
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