510(k) Report

510(k) · Cleared

Cleared

Air-Powered Handpieces and Handpiece Attachments

K162926510(k) TraditionalCleared Feb 23, 2017127-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

W&H Dentalwerk Burmoos GmbH · EFB Handpiece, Air-Powered, Dental

Cleared on Feb 23, 2017 as substantially equivalent to K143704 (W&H Dentalwerk Buermoos GmbH, 2015) and 1 other predicate after a 127-day review. Its family tree reaches back 4 generations to 1998. 6 later devices descend from it.

Decided
Feb 23, 2017
Review
127 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K983183 (1998). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2001: 2 other ancestors2019: 1 descendant cleared2024: 4 descendants cleared2022: 1 descendant clearedK983183 · Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P · Bien Air USA, Inc. · 1998K031145 · Estylus Electric Motor System · Dentsply Intl. · 2003K072989 · Axis System · Dentsply Intl., Inc. · 2008K143704 · Advanced Air System · W&H Dentalwerk Buermoos GmbH · 20151995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K143704 · Advanced Air System · W&H Dentalwerk Buermoos GmbH · 2015K072989 · Axis System · Dentsply Intl., Inc. · 2008K031145 · Estylus Electric Motor System · Dentsply Intl. · 2003K983183 · Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P · Bien Air USA, Inc. · 19980
  1. Root · 4 generations backK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
  2. 3 generations backK031145 Estylus Electric Motor SystemDentsply Intl. · 2003
  3. 2 generations backK072989 Axis SystemDentsply Intl., Inc. · 2008
  4. 1 generation backK143704 Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015
  5. This deviceK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017
  6. Descendant · cites it directly · 4 of its ownK181858 Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019
  7. Descendant · 2 generations on · 1 of its ownK213022 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L…Cefla S.C. · 2022
  8. Descendant · 2 generations on · 0 of its ownK233288 NLZ Built-In Motor SystemNakanishi, Inc. · 2024
  9. Descendant · cites it directly · 0 of its ownK233308 Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc. · 2024
  10. Descendant · 3 generations on · 0 of its ownK230895 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs…Cefla S.C. · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019: 12022: 12024: 4
2019high 4 (2024) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all
  • K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019 · cites it directly4descendants
  • K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…Cefla S.C. · 2022 · 2 generations on1descendant
  • K233288NLZ Built-In Motor SystemNakanishi, Inc. · 2024 · 2 generations on0descendants
  • K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc. · 2024 · cites it directly0descendants
  • K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…Cefla S.C. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K983183Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon…Bien Air USA, Inc.1998—
−3K031145Estylus Electric Motor SystemDentsply Intl.2003—
−2K072989Axis SystemDentsply Intl., Inc.2008—
−1K143704Advanced Air SystemW&H Dentalwerk Buermoos GmbH2015—
0 (this device)K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH2017—
+1K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH2019—
+2K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy…Cefla S.C.2022—
+2K233288NLZ Built-In Motor SystemNakanishi, Inc.2024—
+1K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc.2024—
+3K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO…Cefla S.C.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202210
202440
FIG. 1 — Lineage of K162926, 1998–2024Source: 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), 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 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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K143704Advanced Air System
Summary page 4
…Primary Predicate: “Advanced Air System”, W&H Dentalwerk Bürmoos GmbH; cleared under K143704. Reference Predicates: “A-dec/W&H Synea Air-Driven Highspeed Handpiece…
W&H Dentalwerk Buermoos GmbH2015—
*K070663A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, a-Dec/W&H Synea…
Summary page 4
…“A-dec/W&H Synea Air-Driven Highspeed Handpiece, Predicate Devices “A-dec/W&H Synea Handpiece Attachment” cleared under K070663 The predicates have not been subject to a design-related recall. R…
A-Dec, Inc.2007—

Also cleared against K143704: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH20194
K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc.20240

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?

  • The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K181858 (W&H Dentalwerk Buermoos GmbH, 2019) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K143704.

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. 2017, this device’s year, is highlighted.

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—

What is it indicated for?

The turbine handpiece is intended for the following applications:

Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces.

The dental handpiece/contra-angle is intended for the following applications: Removal of decayed materials, cavities and crown cement, removal of fillings, finishing and polishing of tooth and restoration surfaces.

Indications for use as stated in the FDA summary.

Also cleared against K143704

1 other device cites the same predicate.

  • K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)Nakanishi, Inc. · 2024

More from W&H Dentalwerk Burmoos GmbH

2 FDA decisions under this applicant name. See the company

  • K161957W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH · 2016

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/K162926 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162926: Air-Powered Handpieces and Handpiece Attachments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162926

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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