510(k) · Cleared

Cleared

Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories

K052741510(k) TraditionalCleared Jan 13, 2006105-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 Buermoos GmbH · EBW Controller, Foot, Handpiece And Cord

Cleared on Jan 13, 2006 as substantially equivalent to K002469 (W&H Dentalwerk Buermoos GmbH, 2001) after a 105-day review. Its family tree reaches back 1 generation to 2001. 27 later devices descend from it.

Decided: Jan 13, 2006
Review: 105 days
Class: Class I
Product code: EBW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002469 (2001). 27 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
This deviceK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
Descendant · cites it directly · 8 of its ownK161957 W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH · 2016
Descendant · 2 generations on · 5 of its ownK173905 Surgic Pro, Surgic Pro+Nakanishi, Inc. · 2018
Descendant · cites it directly · 4 of its ownK123695 Traus SIP10Saeshin Precision Co., Ltd. · 2012
Descendant · cites it directly · 4 of its ownK092214 Chiropro L SystemBien-Air Dental, SA · 2009 · Recalled
Descendant · cites it directly · 3 of its ownK080939 Surgical Handpieces, Mikro Saw HandpiecesW&H Dentalwerk Buermoos GmbH · 2008 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2006high 4 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 27 · See all

K161957W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH · 2016 · cites it directly8descendants
K173905Surgic Pro, Surgic Pro+Nakanishi, Inc. · 2018 · 2 generations on5descendants
K123695Traus SIP10Saeshin Precision Co., Ltd. · 2012 · cites it directly4descendants
K092214Chiropro L SystemBien-Air Dental, SA · 2009 · cites it directly4descendants
K080939Surgical Handpieces, Mikro Saw HandpiecesW&H Dentalwerk Buermoos GmbH · 2008 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002469	Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)	W&H Dentalwerk Buermoos GmbH	2001	—
0 (this device)	K052741	Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.…	W&H Dentalwerk Buermoos GmbH	2006	—
+1	K161957	W&H Implantmed SI-1015 incl. Accessories	W&H Dentalwerk Burmoos GmbH	2016	—
+2	K173905	Surgic Pro, Surgic Pro+	Nakanishi, Inc.	2018	—
+1	K123695	Traus SIP10	Saeshin Precision Co., Ltd.	2012	—
+1	K092214	Chiropro L System	Bien-Air Dental, SA	2009	1
+1	K080939	Surgical Handpieces, Mikro Saw Handpieces	W&H Dentalwerk Buermoos GmbH	2008	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2009	2	0
2010	1	0
2011	2	0
2012	2	0
2014	1	0
2015	2	0
2016	1	0
2017	2	0
2018	1	0
2020	2	0
2021	4	0
2022	2	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K052741, 2001–2026Source: 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 EBW? 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 EBW device

#1 K251701 Star E900 Electric Systemscore 12.2 · 6 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? (1)

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
*	K002469	Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) Summary page 1 …and maxillo surgery Classification Name: Controller, foot, handpiece and cord Predicate device: implantMED (K002469) Device ecipin The implantMVED S1-915/923 consist of a small hand held motor, a foot control and a controller. Accessories…	W&H Dentalwerk Buermoos GmbH	2001	—

Also cleared against K002469: 1 other device →

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K161957	W&H Implantmed SI-1015 incl. Accessories	W&H Dentalwerk Burmoos GmbH	2016	8
K123695	Traus SIP10	Saeshin Precision Co., Ltd.	2012	4
K092214	Chiropro L System	Bien-Air Dental, SA	2009	4
K080939	Surgical Handpieces, Mikro Saw Handpieces	W&H Dentalwerk Buermoos GmbH	2008	3
K100600	Prosthodontic Screwdriver , Model IA-400	W&H Dentalwerk Buermoos GmbH	2010	2
K092758	X-CUBE	Saeshin Precision Co., Ltd.	2009	1
K102241	Anthogyr Implanteo Implantology and Dental Surgical Motor Unit	Anthogyr Sas	2011	0
K060287	Drilltech, Ism, Implantunit, Zimmer Surgical Motor System	W&H Dentalwerk Buermoos GmbH	2006	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?

Its one ancestor has no recall.
Of its descendants, K161957 (W&H Dentalwerk Burmoos GmbH, 2016) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K002469.

How does its category compare?

All EBW devices

EBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBW

3in 2025

2007high 6 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBW

220in 2025

2007high 479 (2022) · low 112 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBW

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBW

13in 2025

2007high 71 (2020) · low 0 (2007)2025

MAUDE reports naming product code EBW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	5	112	0	16
2010	1	—	0	18
2011	3	226	0	1
2012	1	—	0	5
2013	1	—	1	1
2014	3	189	0	4
2015	1	—	0	13
2016	1	—	0	6
2017	4	227	0	13
2018	1	—	0	46
2019	2	—	0	55
2020	1	—	0	71
2021	2	—	0	57
2022	6	479	0	31
2023	0	—	0	17
2024	4	268	0	14
2025	3	220	0	13
2026	3	269	0	—

What is it indicated for?

Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology, maxillo-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052741 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052741

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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