510(k) · Cleared
ClearedCodent Low Speed Dental 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 Oct 24, 2014 as substantially equivalent to K070663 (A-Dec, Inc., 2007) and 1 other predicate after a 389-day review. Its family tree reaches back 2 generations to 1998. 6 later devices descend from it.
- Decided
- Oct 24, 2014
- Review
- 389 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983183 (1998). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
- 1 generation backK083101 Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight…Sable Industries, Inc. · 2009
- This deviceK133069 Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2014
- Descendant · cites it directly · 5 of its ownK150798 Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK170236 Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
- Descendant · 3 generations on · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
- Descendant · 4 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 ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150798Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · cites it directly5descendants
- K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 2 generations on4descendants
- K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · 3 generations on2descendants
- K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2023 · 4 generations on1descendant
- K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983183 | Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon… | Bien Air USA, Inc. | 1998 | — |
| −1 | K083101 | Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight Nosecones | Sable Industries, Inc. | 2009 | — |
| 0 (this device) | 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 | — |
| +2 | K170236 | Dental Low-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
| +3 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | 2020 | — |
| +4 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle… | Foshan Coxo Medical Instrument Co., Ltd. | 2023 | — |
| +2 | K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS… | Foshan Topmed Dental Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea…Summary page 4…WA-99LT, WA-86LT, WA-66LT, WA-56LT, HA-43LT Manufacturer: A-DEC, INC. 510(k) Number: K070663 Predicate Device Name: Premium Slow Speed Dental Handpieces and Accessorie… | 2007 |
| * | K083101 | Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight NoseconesSummary page 5…Codent Low Speed Dental 510(k) Notification, K133069-RTA Handpieces and Accessories 510(k) Number: K083101 6. Intended Use and Indications for Use of the subject device. Codent Low Speed Dental Handpieces and Accessories a… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150798 | Codent Low Speed Dental Handpieces and Accessories | 2015 | 5 |
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 16 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K150798 (Codent Technical Industry Co., Ltd., 2015) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K070663.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Codent Low Speed Dental 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/K133069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133069: Codent Low Speed Dental Handpieces and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133069
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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