510(k) Report

510(k) · Cleared

Cleared

Handpiece System with Motor (Several Models)

K896878510(k) TraditionalCleared Mar 8, 199090-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

Micro Motors, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Mar 8, 1990 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Mar 8, 1990
Review
90 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2008: 1 descendant cleared2014: 1 descendant cleared2026: 1 descendant cleared2010: 1 descendant cleared1990200020102020
  1. This deviceK896878 Handpiece System with Motor (Several Models)Micro Motors, Inc. · 1990
  2. Descendant · cites it directly · 3 of its ownK073652 ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece…Nakamura Magnifier Co., Ltd. · 2008
  3. Descendant · cites it directly · 1 of its ownK092446 Intra Lux Head 3 LdsyKaltenbach & Voigt GmbH & Co. · 2009
  4. Descendant · 2 generations on · 0 of its ownK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
  5. Descendant · 2 generations on · 0 of its ownK141125 U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014
  6. Descendant · 2 generations on · 0 of its ownK101172 RDT3 Handpiece Head Model RDT3Redent Nova, Ltd. · 2010

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 12014: 12026: 1
2008high 2 (2009) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K073652ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…Nakamura Magnifier Co., Ltd. · 2008 · cites it directly3descendants
  • K092446Intra Lux Head 3 LdsyKaltenbach & Voigt GmbH & Co. · 2009 · cites it directly1descendant
  • K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · 2 generations on0descendants
  • K141125U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014 · 2 generations on0descendants
  • K101172RDT3 Handpiece Head Model RDT3Redent Nova, Ltd. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896878Handpiece System with Motor (Several Models)Micro Motors, Inc.1990—
+1K073652ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type…Nakamura Magnifier Co., Ltd.2008—
+1K092446Intra Lux Head 3 LdsyKaltenbach & Voigt GmbH & Co.2009—
+2K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.2026—
+2K141125U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters2014—
+2K101172RDT3 Handpiece Head Model RDT3Redent Nova, Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201010
201410
202610
FIG. 1 — Lineage of K896878, 1990–2026Source: 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
Get a 510(k) Report

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? (6)

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

NumberDeviceApplicantDecidedDescendants
K073652ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…Nakamura Magnifier Co., Ltd.20083
K092446Intra Lux Head 3 LdsyKaltenbach & Voigt GmbH & Co.20091

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, K073652 (Nakamura Magnifier Co., Ltd., 2008) has gone furthest, with 3 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—

More from Micro Motors, Inc.

14 FDA decisions under this applicant name. See the company

  • K000120Pro-TorqMicro Motors, Inc. · 2000
  • K991283Dyna Torq Torque Wrench, Torque WrenchMicro Motors, Inc. · 19991 recall
  • K963843Electric Surgical Irrigation System - Dual Controller UnitMicro Motors, Inc. · 1997
  • K970002Sterile Water PumpMicro Motors, Inc. · 1997
  • K942380Micro Ics Sonic ScalerMicro Motors, Inc. · 1995

Recent decisions in EFB

The EFB category page

  • K260029Firstar Dental HandpiecesFDC Technology Industry Co. · 2026
  • K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
  • K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd. · 2026
  • K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB…Foshan Topmed Dental Co., Ltd. · 2026
  • K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbH · 2025

https://510kreport.com/device/K896878 · printed Nov 4, 2026

Cite this page

510(k) Report. “K896878: Handpiece System with Motor (Several Models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896878

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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