510(k) · Cleared
ClearedStar E900 Electric System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez, Inc., Stardental Division · EBW Controller, Foot, Handpiece And Cord
Cleared on Jan 12, 2026 as substantially equivalent to K163402 (Nakanishi, Inc., 2017) after a 224-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jan 12, 2026
- Review
- 224 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K970339 (1997). 18 ancestors in all, the oldest K964860 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- 5 generations backK022147 Denta PortJ. Morita USA, Inc. · 2002
- 4 generations backK031204 Dentaport ZXJ. Morita USA, Inc. · 2003
- 3 generations backK042822 TCM Endo V, Model 1534Nouvag AG · 2004
- 2 generations backK150750 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015
- 1 generation backK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- This deviceK251701 Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| −5 | K022147 | Denta Port | J. Morita USA, Inc. | 2002 | — |
| −4 | K031204 | Dentaport ZX | J. Morita USA, Inc. | 2003 | — |
| −3 | K042822 | TCM Endo V, Model 1534 | Nouvag AG | 2004 | — |
| −2 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015 | — |
| −1 | K163402 | NLZ Motor System | Nakanishi, Inc. | 2017 | — |
| 0 (this device) | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 K251811 Motor and Apex Module (MaAM)score 12.0 · 8 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 |
|---|---|---|---|
| * | K163402 | NLZ Motor SystemSummary page 5…R 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EBW III. PREDICATE DEVICE Clearance: K163402 dated August 31, 2017 Manufacturer: Nakanishi, Inc. Trade/Device Name: NLZ Motor System Common Name: Co… | 2017 |
| † | K240183 | Star E900 Handpiece Series | 2024 |
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.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- None of the 18 ancestors has a 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. 2026, 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?
The Star E900 Electric System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251701 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251701: Star E900 Electric System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251701
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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