510(k) · Cleared
ClearedCordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Dec 15, 2009 as substantially equivalent to K970339 (J. Morita USA, Inc., 1997) after a 257-day review. Its family tree reaches back 1 generation to 1997. 11 later devices descend from it.
- Decided
- Dec 15, 2009
- Review
- 257 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970339 (1997). 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- This deviceK090931 Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorW&H Dentalwerk Buermoos GmbH · 2009
- Descendant · cites it directly · 3 of its ownK123582 Endo a ClassSaeyang Microtech Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK150750 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015
- Descendant · cites it directly · 2 of its ownK100600 Prosthodontic Screwdriver , Model IA-400W&H Dentalwerk Buermoos GmbH · 2010
- Descendant · 2 generations on · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK143411 Traus EndoSaeshin Precision Co., Ltd. · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K123582Endo a ClassSaeyang Microtech Co., Ltd. · 2013 · cites it directly3descendants
- K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015 · cites it directly2descendants
- K100600Prosthodontic Screwdriver , Model IA-400W&H Dentalwerk Buermoos GmbH · 2010 · cites it directly2descendants
- K163402NLZ Motor SystemNakanishi, Inc. · 2017 · 2 generations on1descendant
- K143411Traus EndoSaeshin Precision Co., Ltd. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| 0 (this device) | K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor | W&H Dentalwerk Buermoos GmbH | 2009 | — |
| +1 | K123582 | Endo a Class | Saeyang Microtech Co., Ltd. | 2013 | — |
| +1 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015 | — |
| +1 | K100600 | Prosthodontic Screwdriver , Model IA-400 | W&H Dentalwerk Buermoos GmbH | 2010 | — |
| +2 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
| +2 | K143411 | Traus Endo | Saeshin Precision Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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 EKX? 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 EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K970339 | Tri Auto ZXSummary page 1…ion Number 21 CIFR872.4200 Product Code EKX Predicate Devices "Tri Auto ZX', J. Morita USA Inc., K970339 Device Description The cordless; ENDO-handpiece EB-300 (EB-300 S) consists of… | 1997 |
What descends from it? (11)
See all 114 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?
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 1 | — | 0 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument (»>ENDO file<<),
which is intended by the manufacturer for use in the mechanical and rotary preparation of the root canal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090931: Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090931
Report an extraction error
Are you the manufacturer?
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