510(k) · Cleared
Recalled · 2006Star Dental 430 Series High Speed Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez Group · EFA Handpiece, Belt And/Or Gear Driven, Dental
Cleared on Mar 28, 1996 after a 36-day review. The FDA summary names its predicate without a number. 30 later devices descend from it. It has been recalled once.
- Decided
- Mar 28, 1996
- Review
- 36 days
- Class
- Class I
- Product code
- EFA
- Recalls
- 1
- Predicates
- 0
30 later devices descend from it, 6 citing it directly.
- This deviceK960719 Star Dental 430 Series High Speed HandpieceDentalez Group · 1996
- Descendant · cites it directly · 24 of its ownK965238 T1 Control High Speed Dental HandpieceSiemens AG · 1997
- Descendant · cites it directly · 23 of its ownK073478 Supertorque High-Speed Handpieces and Gentlepower Handpieces and…Sybron Dental Specialties, Inc. · 2008
- Descendant · 2 generations on · 13 of its ownK102517 Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011
- Descendant · cites it directly · 9 of its ownK130455 430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013
- Descendant · 2 generations on · 8 of its ownK152146 High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K965238T1 Control High Speed Dental HandpieceSiemens AG · 1997 · cites it directly24descendants
- K073478Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsSybron Dental Specialties, Inc. · 2008 · cites it directly23descendants
- K102517Tiger 500 Series High Speed Handpieces and AttachmentsThunder Tiger Corp. · 2011 · 2 generations on13descendants
- K130455430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013 · cites it directly9descendants
- K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960719 | Star Dental 430 Series High Speed Handpiece | Dentalez Group | 1996 | — |
| +1 | K965238 | T1 Control High Speed Dental Handpiece | Siemens AG | 1997 | — |
| +1 | K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements | Sybron Dental Specialties, Inc. | 2008 | — |
| +2 | K102517 | Tiger 500 Series High Speed Handpieces and Attachments | Thunder Tiger Corp. | 2011 | — |
| +1 | K130455 | 430 SWL 45 and 430 SW 45 High-Speed Handpieces | Dentalez Group, Stardental Division | 2013 | — |
| +2 | K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 EFA? 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 EFA device
- #1 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Star Dental 430 Series High Speed Handpiece Named without a submission number |
What descends from it? (30)
See all 306 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K965238 | T1 Control High Speed Dental Handpiece | 1997 | 24 |
| K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements | 2008 | 23 |
| K130455 | 430 SWL 45 and 430 SW 45 High-Speed Handpieces | 2013 | 9 |
| K113301 | Concenpiece,High-Speed Handpiece Series | 2012 | 1 |
| K062219 | Prodrive Systems Replacement Turbine | 2006 | 0 |
| K030133 | Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus… | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2006 | Not classified | Z-0313-2007 | Other | End cap component can disassemble. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K965238 (Siemens AG, 1997) has gone furthest, with 24 descendants of its own.
How does its category compare?
All EFA devicesEFA Handpiece, Belt And/Or Gear Driven, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EFA
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFA
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFA
4in 2025
MAUDE reports naming product code EFA, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 4 | 78 | 0 | 0 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960719 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960719: Star Dental 430 Series High Speed Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960719
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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