510(k) · Cleared
ClearedMK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light Power System, Models: LS2011
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 3, 2005 as substantially equivalent to K993526 (A-Dec, Inc., 2000) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1976. 2 later devices descend from it.
- Decided
- Oct 3, 2005
- Review
- 84 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K760929 (1976). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK760929 Accutorq IIRitter Co. · 1976
- 2 generations backK021250 MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012…Handpiece Unlimited · 2002
- 1 generation backK032234 MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K…Mk-Dent GmbH · 2003
- This deviceK051872 MK-Dent Low Speed Handpieces and Accessories Including Spare Parts…Mk-Dent GmbH · 2005
- Descendant · cites it directly · 1 of its ownK070155 Integrity Low Speed Dental Air Handpiece and Attachment, Models…Osseo Scientific, LLC · 2007
- Descendant · 2 generations on · 0 of its ownK093971 Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010
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 |
|---|---|---|---|---|---|
| −3 | K760929 | Accutorq II | Ritter Co. | 1976 | — |
| −2 | K021250 | MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard… | Handpiece Unlimited | 2002 | — |
| −1 | K032234 | MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS… | Mk-Dent GmbH | 2003 | — |
| 0 (this device) | K051872 | MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings… | Mk-Dent GmbH | 2005 | — |
| +1 | K070155 | Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E… | Osseo Scientific, LLC | 2007 | — |
| +2 | K093971 | Dental Handpiece | North West Medical Instrument (Group) Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K993526 | Synea - LS Low-Speed HandpieceSummary page 2…handpieces for use by a trained professional in general dentistry. Predicate Device Name: A-dec/W&H Synea Low Speed (K993526); with respect to used materials: MK-dentr High Speed Dental Handpiec… | 2000 |
| * | K021250 | MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS…Summary page 2…A-dec/W&H Synea Low Speed (K993526); with respect to used materials: MK-dentr High Speed Dental Handpiece (K021250, K032234) Description of Device: The MK-dent® Low Speed Handpieces are compatible to air an… | 2002 |
| * | K032234 | MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K…Summary page 2…W&H Synea Low Speed (K993526); with respect to used materials: MK-dentr High Speed Dental Handpiece (K021250, K032234) Description of Device: The MK-dent® Low Speed Handpieces are compatible to air and electri… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070155 | Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor… | 2007 | 1 |
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 29 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070155 (Osseo Scientific, LLC, 2007) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K993526.
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 a low speed dental handpiece for use by a trained professional in general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051872 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051872: MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light Power System, Models: LS2011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051872
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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