510(k) · Cleared

Cleared

MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS 2014 (Small Head)

K021250510(k) TraditionalCleared Oct 24, 2002188-day reviewClass II21 CFR 872.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Handpiece Unlimited · EBF Material, Tooth Shade, Resin

Cleared on Oct 24, 2002 as substantially equivalent to K760929 (Ritter Co., 1976) after a 188-day review. Its family tree reaches back 1 generation to 1976. 6 later devices descend from it.

Decided: Oct 24, 2002
Review: 188 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K760929 (1976). 6 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK760929 Accutorq IIRitter Co. · 1976
This deviceK021250 MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012…Handpiece Unlimited · 2002
Descendant · cites it directly · 3 of its ownK032234 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 · cites it directly · 1 of its ownK101551 Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010
Descendant · 2 generations on · 1 of its ownK070155 Integrity Low Speed Dental Air Handpiece and Attachment, Models…Osseo Scientific, LLC · 2007
Descendant · cites it directly · 0 of its ownK112623 Airlight Dental HandpieceBeyes Dental Canada, Inc. · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003high 2 (2010) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all

K032234MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K…Mk-Dent GmbH · 2003 · cites it directly3descendants
K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light…Mk-Dent GmbH · 2005 · cites it directly2descendants
K101551Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010 · cites it directly1descendant
K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor…Osseo Scientific, LLC · 2007 · 2 generations on1descendant
K112623Airlight Dental HandpieceBeyes Dental Canada, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K760929	Accutorq II	Ritter Co.	1976	—
0 (this device)	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	—
+1	K051872	MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings…	Mk-Dent GmbH	2005	—
+1	K101551	Pacemaker High-Speed Handpiece Model PM-MQ, PM-M	Delma Medical Instrument (Guangzhou) Co., Ltd.	2010	—
+2	K070155	Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E…	Osseo Scientific, LLC	2007	—
+1	K112623	Airlight Dental Handpiece	Beyes Dental Canada, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2007	1	0
2010	2	0
2011	1	0

FIG. 1 — Lineage of K021250, 1976–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 EBF? 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 EBF device

#1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K760929	Accutorq II Summary page 1 …Class I Product Code 76 EFB 4.2 Equivalent Device Equivalent legally marketed device: KaVo 625 Dental Handpiece (K760929) 4.3 Indications for Use The device is an air-powered dental handpiece for use by a trained professional in general d…	Ritter Co.	1976	—

Also cleared against K760929: 2 other devices →

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032234	MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K…	Mk-Dent GmbH	2003	3
K051872	MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light…	Mk-Dent GmbH	2005	2
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	0

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, K032234 (Mk-Dent GmbH, 2003) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K760929.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)2025

MAUDE reports naming product code EBF, 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	19	49	1	6
2008	14	79	42	10
2009	20	84	1	8
2010	19	75	6	31
2011	19	81	7	31
2012	11	86	0	62
2013	13	153	0	246
2014	10	112	0	195
2015	17	123	0	119
2016	20	205	0	143
2017	15	108	4	42
2018	15	115	0	8
2019	17	159	2	11
2020	15	190	1	2
2021	13	178	0	2
2022	17	63	0	2
2023	9	87	0	8
2024	18	120	0	5
2025	15	43	0	1
2026	16	59	2	—

What is it indicated for?

The device is an air-powered dental handpiece for use by a

trained professional in general dentistry.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021250 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021250: MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS 2014 (Small Head).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021250

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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