510(k) Report

510(k) · Cleared

Cleared

Dental Air Motors (Several Models)

K896877510(k) TraditionalCleared Mar 7, 199089-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 7, 1990 after an 89-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 7, 1990
Review
89 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2017: 1 descendant cleared2008: 1 descendant cleared2014: 1 descendant cleared2009: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK896877 Dental Air Motors (Several Models)Micro Motors, Inc. · 1990
  2. Descendant · cites it directly · 5 of its ownK070869 Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc. · 2007
  3. Descendant · 2 generations on · 3 of its ownK073652 ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece…Nakamura Magnifier Co., Ltd. · 2008
  4. Descendant · 3 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 ownK170261 Premium Plus Prophy Air MotorPremium Plus International Limited · 2017
  6. Descendant · 3 generations on · 0 of its ownK141125 U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12014: 12017: 12026: 1
2007high 1 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K070869Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc. · 2007 · cites it directly5descendants
  • K073652ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…Nakamura Magnifier Co., Ltd. · 2008 · 2 generations on3descendants
  • K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · 3 generations on0descendants
  • K170261Premium Plus Prophy Air MotorPremium Plus International Limited · 2017 · 2 generations on0descendants
  • K141125U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters · 2014 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896877Dental Air Motors (Several Models)Micro Motors, Inc.1990—
+1K070869Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc.2007—
+2K073652ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type…Nakamura Magnifier Co., Ltd.2008—
+3K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.2026—
+2K170261Premium Plus Prophy Air MotorPremium Plus International Limited2017—
+3K141125U-Type Contra Angle, U-Type Sectional Contra AngleHandpiece Headquarters2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201410
201710
202610
FIG. 1 — Lineage of K896877, 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
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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? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070869Prophy Star 3 Hygiene Handpiece, Model 264422Dentalez, Inc.20075

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, K070869 (Dentalez, Inc., 2007) has gone furthest, with 5 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. “K896877: Dental Air Motors (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/K896877

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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