510(k) · Cleared

Cleared

Estylus Electric Motor System

K031145510(k) TraditionalCleared Jul 15, 200396-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

Dentsply Intl. · EFB Handpiece, Air-Powered, Dental

Cleared on Jul 15, 2003 as substantially equivalent to K983183 (Bien Air USA, Inc., 1998) and 1 other predicate after a 96-day review. Its family tree reaches back 1 generation to 1998. 10 later devices descend from it.

Decided: Jul 15, 2003
Review: 96 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K983183 (1998). 2 ancestors in all. 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
This deviceK031145 Estylus Electric Motor SystemDentsply Intl. · 2003
Descendant · cites it directly · 8 of its ownK072989 Axis SystemDentsply Intl., Inc. · 2008
Descendant · 2 generations on · 7 of its ownK143704 Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015
Descendant · 3 generations on · 6 of its ownK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017
Descendant · 4 generations on · 4 of its ownK181858 Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019
Descendant · 5 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

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2004high 4 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all

K072989Axis SystemDentsply Intl., Inc. · 2008 · cites it directly8descendants
K143704Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015 · 2 generations on7descendants
K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017 · 3 generations on6descendants
K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019 · 4 generations on4descendants
K213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…Cefla S.C. · 2022 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983183	Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon…	Bien Air USA, Inc.	1998	—
0 (this device)	K031145	Estylus Electric Motor System	Dentsply Intl.	2003	—
+1	K072989	Axis System	Dentsply Intl., Inc.	2008	—
+2	K143704	Advanced Air System	W&H Dentalwerk Buermoos GmbH	2015	—
+3	K162926	Air-Powered Handpieces and Handpiece Attachments	W&H Dentalwerk Burmoos GmbH	2017	—
+4	K181858	Electric Handpiece Motor	W&H Dentalwerk Buermoos GmbH	2019	—
+5	K213022	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy…	Cefla S.C.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2015	1	0
2017	1	0
2019	1	0
2022	1	0
2024	4	0

FIG. 1 — Lineage of K031145, 1998–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K983183	Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch… Summary page 1 …CLASSIFICATION NAME: Dental handpieces and accessories (872.4200) PREDICATE DEVICES: Bien-Air’s Dental Handpieces K983 183 TCM Endo I11 Dental Handpiece KO1 3 185 DEVICE DESCRIPTION: The eSTYLUSTMEL…	Bien Air USA, Inc.	1998	—
*	K013185	TCM Endo Iii	Nouvag AG	2001	—

Also cleared against K983183: 3 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K072989	Axis System	Dentsply Intl., Inc.	2008	8
K042787	IS 40 Micromotor	Satelec	2004	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K072989 (Dentsply Intl., Inc., 2008) has gone furthest, with 8 descendants of its own.
3 other devices also cite its predicate K983183.

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

2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	12	61	13
2008	7	97	19
2009	11	120	40
2010	8	116	78
2011	4	168	96
2012	8	130	97
2013	3	207	61
2014	7	200	73
2015	7	296	87
2016	3	205	122
2017	7	246	153
2018	3	210	81
2019	3	348	117
2020	5	259	94
2021	2	—	123
2022	5	430	157
2023	4	158	116
2024	5	209	104
2025	1	—	83
2026	4	252	—

What is it indicated for?

Used in general dentistry and endodontic dentistry for cutting, shaping,, filing, drilling, cleaning and polishing procedures

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031145 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031145: Estylus Electric Motor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031145

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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