510(k) · Cleared
ClearedEndo E Class
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saeyang Microtech Co., Ltd. · EBW Controller, Foot, Handpiece And Cord
Cleared on Aug 16, 2013 as substantially equivalent to K111078 (Aseptico, Inc., 2011) and 2 other predicates after a 268-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Aug 16, 2013
- Review
- 268 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K970339 (1997). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- 3 generations backK022147 Denta PortJ. Morita USA, Inc. · 2002
- 2 generations backK031204 Dentaport ZXJ. Morita USA, Inc. · 2003
- 1 generation backK042822 TCM Endo V, Model 1534Nouvag AG · 2004
- This deviceK123608 Endo E ClassSaeyang Microtech Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK141482 KI-20Saeyang Microtech Co., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K141482KI-20Saeyang Microtech Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| −3 | K022147 | Denta Port | J. Morita USA, Inc. | 2002 | — |
| −2 | K031204 | Dentaport ZX | J. Morita USA, Inc. | 2003 | — |
| −1 | K042822 | TCM Endo V, Model 1534 | Nouvag AG | 2004 | — |
| 0 (this device) | K123608 | Endo E Class | Saeyang Microtech Co., Ltd. | 2013 | — |
| +1 | K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (3)
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 |
|---|---|---|---|
| * | K111078 | Aeu-26L Elctronic Endodontic SystemSummary page 2…ivalent to the predicate devices. Subject Device Predicate 1 Predicate 2 Predicate 3 510(k) Number K1 23608 K1 11078 K000547 K042822 Device Name ENDO EClass AEU-26L ATH TECNIKA TCM ENDO V… | 2011 |
| * | K042822 | TCM Endo V, Model 1534Summary page 1…lass 1,21 CFR Part 872.4200, Product Code EBW. 3. Predicate Device Information: 1. KlllO7BAseptico, Inc's AEU-26L Electronic Endodontic System 2. K042822 Nouvag Ag's TCMV Endo V, Model 1534 3. K000547 A.T.R.'S TECNIKA 4. Device Description: The motor… | 2004 |
| * | K000547 | Atr TecnikaSummary page 1…3. Predicate Device Information: 1. KlllO7BAseptico, Inc's AEU-26L Electronic Endodontic System 2. K042822 Nouvag Ag's TCMV Endo V, Model 1534 3. K000547 A.T.R.'S TECNIKA 4. Device Description: The motor turned by the power converted into DC24V by controll… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141482 | KI-20 | 2015 | 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K141482 (Saeyang Microtech Co., Ltd., 2015) has gone furthest, with 0 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. 2013, this device’s year, is highlighted.
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?
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123608: Endo E Class.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123608
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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