510(k) Report

510(k) · Cleared

Cleared

Accutorq II

K760929510(k) TraditionalCleared Nov 19, 197621-day reviewClass I21 CFR 872.4200

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

Ritter Co. · EFB Handpiece, Air-Powered, Dental

Cleared on Nov 19, 1976 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Nov 19, 1976
Review
21 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
0

8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2002: 2 descendants cleared2005: 1 descendant cleared2010: 2 descendants cleared2011: 1 descendant cleared2007: 1 descendant cleared19801990200020102020
  1. This deviceK760929 Accutorq IIRitter Co. · 1976
  2. Descendant · cites it directly · 6 of its ownK021250 MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012…Handpiece Unlimited · 2002
  3. Descendant · cites it directly · 3 of its ownK032234 MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K…Mk-Dent GmbH · 2003
  4. Descendant · 2 generations on · 2 of its ownK051872 MK-Dent Low Speed Handpieces and Accessories Including Spare Parts…Mk-Dent GmbH · 2005
  5. Descendant · 2 generations on · 1 of its ownK101551 Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010
  6. Descendant · 3 generations on · 1 of its ownK070155 Integrity Low Speed Dental Air Handpiece and Attachment, Models…Osseo Scientific, LLC · 2007

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002: 22003: 12005: 12007: 12010: 22011: 1
2002high 2 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all
  • K021250MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS…Handpiece Unlimited · 2002 · cites it directly6descendants
  • 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 · 2 generations on2descendants
  • K101551Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd. · 2010 · 2 generations on1descendant
  • K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor…Osseo Scientific, LLC · 2007 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K760929Accutorq IIRitter Co.1976—
+1K021250MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard…Handpiece Unlimited2002—
+1K032234MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS…Mk-Dent GmbH2003—
+2K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings…Mk-Dent GmbH2005—
+2K101551Pacemaker High-Speed Handpiece Model PM-MQ, PM-MDelma Medical Instrument (Guangzhou) Co., Ltd.2010—
+3K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E…Osseo Scientific, LLC2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200310
200510
200710
201020
201110
FIG. 1 — Lineage of K760929, 1976–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K021250MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS…Handpiece Unlimited20026
K032234MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K…Mk-Dent GmbH20033
K020113Vector F Series High-Speed Dental HandpiecesVector Research & Development20020

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, K021250 (Handpiece Unlimited, 2002) has gone furthest, with 6 descendants of its own.

How does its category compare?

All EFB devices

EFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFB

1in 2025

2007: 122008: 72009: 112010: 82011: 42012: 82013: 32014: 72015: 72016: 32017: 72018: 32019: 32020: 52021: 22022: 52023: 42024: 52025: 12026 (partial year): 4
2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

2007: 61 days median2008: 97 days median2009: 120 days median2010: 116 days median2011: 168 days median2012: 130 days median2013: 207 days median2014: 200 days median2015: 296 days median2016: 205 days median2017: 246 days median2018: 210 days median2019: 348 days median2020: 259 days median2022: 430 days median2023: 158 days median2024: 209 days median2026 (partial year): 252 days median
2007high 430 (2022) · low 61 (2007)2026

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

2007: 132008: 192009: 402010: 782011: 962012: 972013: 612014: 732015: 872016: 1222017: 1532018: 812019: 1172020: 942021: 1232022: 1572023: 1162024: 1042025: 83
2007high 157 (2022) · low 13 (2007)2025

MAUDE reports naming product code EFB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071261013
2008797019
200911120040
20108116078
20114168096
20128130097
20133207061
20147200073
20157296087
201632050122
201772460153
20183210081
201933480117
20205259094
20212—0123
202254300157
202341580116
202452090104
20251—083
202642520—
Cite this page

510(k) Report. “K760929: Accutorq II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760929

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026