510(k) · Cleared
ClearedCST61 High Speed Turbine Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Dental Instrument Factory · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 26, 2006 as substantially equivalent to K022535 (Microtech, 2002) after a 15-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Oct 26, 2006
- Review
- 15 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022535 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK022535 Microtech Push Button Handpiece, Model MHS-A100Microtech · 2002
- This deviceK063110 CST61 High Speed Turbine HandpieceShanghai Dental Instrument Factory · 2006
- Descendant · cites it directly · 1 of its ownK101551 Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK112623 Airlight Dental HandpieceBeyes Dental Canada, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022535 | Microtech Push Button Handpiece, Model MHS-A100 | Microtech | 2002 | — |
| 0 (this device) | K063110 | CST61 High Speed Turbine Handpiece | Shanghai Dental Instrument Factory | 2006 | — |
| +1 | K101551 | Pacemaker High-Speed Handpiece Model PM-MQ, PM-M | Delma Medical Instrument (Guangzhou) Co., Ltd. | 2010 | — |
| +1 | K112623 | Airlight Dental Handpiece | Beyes Dental Canada, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K022535 | Microtech Push Button Handpiece, Model MHS-A100Summary page 1…sual name: high speed turbine handpiece 10-Device Classification Name: handpiece, air-powered, dental 11-Substantial Equivalency is claimed against the following device: K022535 12-Description of the Device: CST61 high speed turbine handpiece is an air-powered, hand-held device for use as an operative den… | 2002 |
What descends from it? (2)
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?
- Its one ancestor has no recall.
- Of its descendants, K101551 (Delma Medical Instrument (Guangzhou) Co., Ltd., 2010) has gone furthest, with 1 descendant 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.
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?
CST61 High Speed Turbine Handpiece is indicated for use intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063110: CST61 High 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/K063110
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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