510(k) · Cleared
ClearedMicrotech Push Button Handpiece, Model MHS-A100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microtech · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 22, 2002 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Oct 22, 2002
- Review
- 83 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK022535 Microtech Push Button Handpiece, Model MHS-A100Microtech · 2002
- Descendant · cites it directly · 2 of its ownK063110 CST61 High Speed Turbine HandpieceShanghai Dental Instrument Factory · 2006
- Descendant · 2 generations on · 1 of its ownK101551 Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK112623 Airlight Dental HandpieceBeyes Dental Canada, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K063110CST61 High Speed Turbine HandpieceShanghai Dental Instrument Factory · 2006 · cites it directly2descendants
- K101551Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010 · 2 generations on1descendant
- K112623Airlight Dental HandpieceBeyes Dental Canada, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022535 | Microtech Push Button Handpiece, Model MHS-A100 | Microtech | 2002 | — |
| +1 | K063110 | CST61 High Speed Turbine Handpiece | Shanghai Dental Instrument Factory | 2006 | — |
| +2 | K101551 | Pacemaker High-Speed Handpiece Model PM-MQ, PM-M | Delma Medical Instrument (Guangzhou) Co., Ltd. | 2010 | — |
| +2 | K112623 | Airlight Dental Handpiece | Beyes Dental Canada, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063110 | CST61 High Speed Turbine Handpiece | 2006 | 2 |
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?
- Of its descendants, K063110 (Shanghai Dental Instrument Factory, 2006) has gone furthest, with 2 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.
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?
This handpiece is to be used for 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 510(k) statement.
https://510kreport.com/device/K022535 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022535: Microtech Push Button Handpiece, Model MHS-A100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022535
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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