510(k) · Cleared
ClearedElcomed 100 Types 9925 (W&H- and Innova-Version) and 9927 (Astra-Version), Elcomed 200 Type 9926 (W&H-Version)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W & H Dentalwerk · EBW Controller, Foot, Handpiece And Cord
Cleared on Jan 22, 1998 after a 170-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 22, 1998
- Review
- 170 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
What is it indicated for?
Indications are very widespread in the field of oral surgery ranging from
A. Implant placement, including
1. preparation of the osteotomy site
2. bone recontouring, osteoplasty
B. Bone grafting
1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
2. harvesting autogen living bone
3. sinus elevation & grafting of alveolar sockets
C. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
D. Periodontal surgeries
1. bone recontouring & alveoplasty around living teeth
2. removal of exostosis
E. Endodontic treatment
Intracanal preparations using rotating NiTi-files.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972889: Elcomed 100 Types 9925 (W&H- and Innova-Version) and 9927 (Astra-Version), Elcomed 200 Type 9926 (W&H-Version).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972889
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026