510(k) Report

510(k) · Cleared

Cleared

W&H Air Motor A25

K944711510(k) TraditionalCleared Aug 25, 1995336-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

A-Dec, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Aug 25, 1995 after a 336-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.

Decided
Aug 25, 1995
Review
336 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2012: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant cleared2015: 1 descendant cleared2026: 2 descendants cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK944711 W&H Air Motor A25A-Dec, Inc. · 1995
  2. Descendant · cites it directly · 4 of its ownK112305 Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle…Thunder Tiger Corp. · 2012
  3. Descendant · 2 generations on · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
  4. Descendant · cites it directly · 1 of its ownK053368 Interproximal Reduction SystemDentsply International · 2006
  5. Descendant · 3 generations on · 0 of its ownK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
  6. Descendant · 3 generations on · 0 of its ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12012: 12015: 12021: 12026: 2
2006high 2 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · See all
  • K112305Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low…Thunder Tiger Corp. · 2012 · cites it directly4descendants
  • K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · 2 generations on3descendants
  • K053368Interproximal Reduction SystemDentsply International · 2006 · cites it directly1descendant
  • K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · 3 generations on0descendants
  • K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944711W&H Air Motor A25A-Dec, Inc.1995—
+1K112305Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor…Thunder Tiger Corp.2012—
+2K141886MDK HandpiecesModern Korea Co., Ltd.2015—
+1K053368Interproximal Reduction SystemDentsply International2006—
+3K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.2026—
+3K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS…Foshan Topmed Dental Co., Ltd.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201210
201510
202110
202620
FIG. 1 — Lineage of K944711, 1995–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K112305Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low…Thunder Tiger Corp.20124
K053368Interproximal Reduction SystemDentsply International20061

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, K112305 (Thunder Tiger Corp., 2012) has gone furthest, with 4 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 A-Dec, Inc.

69 FDA decisions under this applicant name. See the company

  • K213932A-dec 300, A-dec 500A-Dec, Inc. · 2022
  • K133776A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
  • K102234A-Dec 200 Dental SystemA-Dec, Inc. · 2010
  • K100647A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMA-Dec, Inc. · 2010
  • K082716A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment…A-Dec, Inc. · 2009

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/K944711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944711: W&H Air Motor A25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944711

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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