510(k) · Cleared
ClearedMK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mk-Dent GmbH · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 2, 2003 as substantially equivalent to K760929 (Ritter Co., 1976) and 1 other predicate after a 73-day review. Its family tree reaches back 2 generations to 1976. 3 later devices descend from it.
- Decided
- Oct 2, 2003
- Review
- 73 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K760929 (1976). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK760929 Accutorq IIRitter Co. · 1976
- 1 generation backK021250 MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012…Handpiece Unlimited · 2002
- This deviceK032234 MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K…Mk-Dent GmbH · 2003
- Descendant · cites it directly · 2 of its ownK051872 MK-Dent Low Speed Handpieces and Accessories Including Spare Parts…Mk-Dent GmbH · 2005
- Descendant · 2 generations on · 1 of its ownK070155 Integrity Low Speed Dental Air Handpiece and Attachment, Models…Osseo Scientific, LLC · 2007
- Descendant · 3 generations on · 0 of its ownK093971 Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See all- K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light…Mk-Dent GmbH · 2005 · cites it directly2descendants
- K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor…Osseo Scientific, LLC · 2007 · 2 generations on1descendant
- K093971Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K760929 | Accutorq II | Ritter Co. | 1976 | — |
| −1 | K021250 | MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard… | Handpiece Unlimited | 2002 | — |
| 0 (this device) | K032234 | MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS… | Mk-Dent GmbH | 2003 | — |
| +1 | K051872 | MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings… | Mk-Dent GmbH | 2005 | — |
| +2 | K070155 | Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E… | Osseo Scientific, LLC | 2007 | — |
| +3 | K093971 | Dental Handpiece | North West Medical Instrument (Group) Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K760929 | Accutorq IISummary page 1…glass optic rod for use by a trained professional in general dentistry. Predicate Device Name: KaVo Dental Handpiece, Series 630 and 640 (K 760929) MK-dent” High Speed Dental Handpiece (K 021250) Description of Device: The MK-dents HS Handpiece s… | 1976 |
| * | K021250 | MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS…Summary page 1…general dentistry. Predicate Device Name: KaVo Dental Handpiece, Series 630 and 640 (K 760929) MK-dent” High Speed Dental Handpiece (K 021250) Description of Device: The MK-dents HS Handpiece shares virtually all specifications and design characteris- tics of the… | 2002 |
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 |
|---|---|---|---|
| K051872 | MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light… | 2005 | 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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 25.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051872 (Mk-Dent GmbH, 2005) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K760929.
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?
The device is an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032234: MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032234
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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