510(k) · Cleared
ClearedImplantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · EBW Controller, Foot, Handpiece And Cord
Cleared on Feb 7, 2001 after a 180-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 28 later devices descend from it.
- Decided
- Feb 7, 2001
- Review
- 180 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly.
- This deviceK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
- Descendant · cites it directly · 27 of its ownK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
- Descendant · 2 generations on · 8 of its ownK161957 W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH · 2016
- Descendant · 3 generations on · 5 of its ownK173905 Surgic Pro, Surgic Pro+Nakanishi, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK123695 Traus SIP10Saeshin Precision Co., Ltd. · 2012
- Descendant · 2 generations on · 4 of its ownK092214 Chiropro L SystemBien-Air Dental, SA · 2009 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K052741Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. AccessoriesW&H Dentalwerk Buermoos GmbH · 2006 · cites it directly27descendants
- K161957W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH · 2016 · 2 generations on8descendants
- K173905Surgic Pro, Surgic Pro+Nakanishi, Inc. · 2018 · 3 generations on5descendants
- K123695Traus SIP10Saeshin Precision Co., Ltd. · 2012 · 2 generations on4descendants
- K092214Chiropro L SystemBien-Air Dental, SA · 2009 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| +1 | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.… | W&H Dentalwerk Buermoos GmbH | 2006 | — |
| +2 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | 2016 | — |
| +3 | K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | 2018 | — |
| +2 | K123695 | Traus SIP10 | Saeshin Precision Co., Ltd. | 2012 | — |
| +2 | K092214 | Chiropro L System | Bien-Air Dental, SA | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 |
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 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
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? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K052741 (W&H Dentalwerk Buermoos GmbH, 2006) has gone furthest, with 27 descendants of its own.
How does its category compare?
All EBW devicesEBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBW
220in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBW
13in 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 | — |
https://510kreport.com/device/K002469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002469: Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002469
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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