510(k) · Cleared
ClearedEndo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Jul 2, 2015 as substantially equivalent to K090931 (W&H Dentalwerk Buermoos GmbH, 2009) and 4 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Jul 2, 2015
- Review
- 101 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K970339 (1997). 10 ancestors in all. 2 later devices descend 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 deviceK150750 Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SpraySirona Dental Systems GmbH · 2015
- Descendant · cites it directly · 1 of its ownK163402 NLZ Motor SystemNakanishi, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK251701 Star E900 Electric SystemDentalez, Inc., Stardental Division · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | 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 | — |
| +2 | K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 EGS? 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 EGS device
- #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorSummary page 4…Regulation Number : 21 CFR 872.4200 Product Code : EGS Classification : II 3 PREDICATE DEVICES Predicate Devices: Root Canal Treatment: K090931 – “W&H ENTRAN K031204 – “Morita DENTAPORT ZX K103653 – “Dentsply E3 Torque Control Motor Root Canal Measurement Support… | 2009 |
| * | K031204 | Dentaport ZXSummary page 4…R 872.4200 Product Code : EGS Classification : II 3 PREDICATE DEVICES Predicate Devices: Root Canal Treatment: K090931 – “W&H ENTRAN K031204 – “Morita DENTAPORT ZX K103653 – “Dentsply E3 Torque Control Motor Root Canal Measurement Support: K031204 – “Morita DE… | 2003 |
| * | K103653 | E3 Torque Control MotorSummary page 4…EGS Classification : II 3 PREDICATE DEVICES Predicate Devices: Root Canal Treatment: K090931 – “W&H ENTRAN K031204 – “Morita DENTAPORT ZX K103653 – “Dentsply E3 Torque Control Motor Root Canal Measurement Support: K031204 – “Morita DENTAPORT ZX K042822 – “Nouvag TC… | 2011 |
| * | K042822 | TCM Endo V, Model 1534Summary page 4…“W&H ENTRAN K031204 – “Morita DENTAPORT ZX K103653 – “Dentsply E3 Torque Control Motor Root Canal Measurement Support: K031204 – “Morita DENTAPORT ZX K042822 – “Nouvag TCM Endo V T1 Spray K113674 – “Spray & Clean Handpiece Cleaner & Lubricant Maxima Handpiece Cleaner & Lub… | 2004 |
| * | K113674 | Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner & Lubricant Ezcare…Summary page 4…ZX K103653 – “Dentsply E3 Torque Control Motor Root Canal Measurement Support: K031204 – “Morita DENTAPORT ZX K042822 – “Nouvag TCM Endo V T1 Spray K113674 – “Spray & Clean Handpiece Cleaner & Lubricant Maxima Handpiece Cleaner & Lubricant EZOARE Handpiece Cleaner & Lubricant”… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163402 | NLZ Motor System | 2017 | 1 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K163402 (Nakanishi, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K090931.
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The contra-angle handpieces are used to hold and drive burr instruments for the purposes of rotary processing. The handpieces are intended for dental applications in endodontics and for root canal measurement and are used by trained dental personnel in dental practices and laboratories. The T1 Spray is intended to be used to clean and lubricate dental handpieces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150750: Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150750
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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