510(k) · Cleared
ClearedDental Low-speed Turbine Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Jinme Medical Technology Co., Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Nov 21, 2017 as substantially equivalent to K150798 (Codent Technical Industry Co., Ltd., 2015) and 1 other predicate after a 300-day review. Its family tree reaches back 4 generations to 1998. 4 later devices descend from it.
- Decided
- Nov 21, 2017
- Review
- 300 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K983183 (1998). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
- 3 generations backK083101 Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight…Sable Industries, Inc. · 2009
- 2 generations backK133069 Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2014
- 1 generation backK150798 Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
- This deviceK170236 Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK220179 High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…Foshan Coxo Medical Instrument Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK241074 High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19…Foshan Soco Precision Instrument Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · cites it directly2descendants
- K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2023 · 2 generations on1descendant
- K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · cites it directly0descendants
- K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…Foshan Soco Precision Instrument Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983183 | Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon… | Bien Air USA, Inc. | 1998 | — |
| −3 | K083101 | Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight Nosecones | Sable Industries, Inc. | 2009 | — |
| −2 | K133069 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2014 | — |
| −1 | K150798 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015 | — |
| 0 (this device) | K170236 | Dental Low-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
| +1 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | 2020 | — |
| +2 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle… | Foshan Coxo Medical Instrument Co., Ltd. | 2023 | — |
| +1 | K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS… | Foshan Topmed Dental Co., Ltd. | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K150798 | Codent Low Speed Dental Handpieces and AccessoriesSummary page 5…bject Device: Dental Low-speed Turbine Handpiece, Models: LN, L File No.: 510(k) Submission Report (V1.0), Chapter 6. 510(k) Summary i 510(K) Number: K150798 i Company Name: Codent Technical Industry Co., Ltd. i Trade Name: Low Speed Handpiece and Accessories i Common Name: Dental Handp… | 2015 |
| * | K163483 | PANA SPRAY Plus Cleared while this submission was under review Summary page 5…y Name: MODERN KOREA Co., Ltd. i Trade Name: MDK handpieces - Low-speed handpieces i Common Name: Dental Handpiece and Accessories i Product Code: EFB Reference Device K163483 i Company Name: NAKANISHI, INC. i Trade Name: Pana Spray Plus i Common Name: Dental Handpiece and Accessories i Product Code: EFB… | 2017 |
| † | K141886 | MDK Handpieces | 2015 |
What descends from it? (4)
2 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 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K181691 (Foshan Wenjian Medical Instrument Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K150798.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Dental Low-speed 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/K170236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170236: Dental Low-speed 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/K170236
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