510(k) · Cleared
Cleared430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Apr 8, 2016 as substantially equivalent to K902402 (Dentalez Group, 1990) after a 135-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Apr 8, 2016
- Review
- 135 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902402 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK902402 High Speed Non-Fiber Optic Swivel HandpieceDentalez Group · 1990
- This deviceK153411 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed…Dentalez, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK192412 SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated…Dentalez, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece…Dentalez, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902402 | High Speed Non-Fiber Optic Swivel Handpiece | Dentalez Group | 1990 | — |
| 0 (this device) | K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece… | Dentalez, Inc. | 2016 | — |
| +1 | K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed… | Dentalez, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K902402 | High Speed Non-Fiber Optic Swivel HandpieceSummary page 4…owered, Dental (21 C.F.R. § 872.4200) Regulatory Class: I Product Code: EFB III. PREDICATE DEVICE: Primary predicate: 430 SW Non-Fiber Optic Handpiece (K902402) Reference predicate: 430 Series High Speed Handpiece (K982593 and K960719) IV. DEVICE DESCRIPTION: The 430 Torque H… | 1990 |
| † | K982593 | Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series… | 1998 |
| † | K960719 | Star Dental 430 Series High Speed Handpiece | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece… | 2020 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K192412 (Dentalez, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 430 Torque High-Speed Handpiece Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153411: 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153411
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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