510(k) · Cleared
ClearedEndoPilot2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schlumbohm GmbH & Co. KG · ELC Scaler, Ultrasonic
Cleared on Apr 13, 2021 as substantially equivalent to K153285 (Meta Systems Co., Ltd., 2016) and 1 other predicate after a 196-day review. Its family tree reaches back 6 generations to 1997. 4 later devices descend from it.
- Decided
- Apr 13, 2021
- Review
- 196 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971350 (1997). 14 ancestors in all, the oldest K942139 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 5 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 4 generations backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- 3 generations backK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- 2 generations backK133298 Endo SmartMeta Biomed, Inc. · 2014
- 1 generation backK153285 EMS-200Meta Systems Co., Ltd. · 2016
- This deviceK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- Descendant · cites it directly · 1 of its ownK233865 X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242317 Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK213947 Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd · 2022
Most influential descendants
Showing 4 of 4 · See all- K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024 · cites it directly1descendant
- K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025 · 2 generations on0descendants
- K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd. · 2025 · cites it directly0descendants
- K213947Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −5 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −4 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| −3 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| −2 | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| −1 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
| 0 (this device) | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| +1 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024 | — |
| +2 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025 | — |
| +1 | K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | 2025 | — |
| +1 | K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | Changzhou Bomedent Medical Technology Co.,Ltd | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 ELC? 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 ELC device
- #1 K260773 Varios Combi Pro2score 12.5 · 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? (2)
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 |
|---|---|---|---|
| * | K153285 | EMS-200Summary page 5…cate Device(s) For the Endodontic unit systems (applicable to all EndoPilot 2model variants): Primary Predicate Device name: EMS-200 510(k) number: K153285 Manufacturer: Meta Systems Co., Ltd., Korea For the Ultrasonic Unit (applicable only to EndoPilot 2 model variant "ult… | 2016 |
| * | K050895 | Surpasson P5 NewtronSummary page 5…trasonic Unit (applicable only to EndoPilot 2 model variant "ultra" and " ultra plus"): Reference Device Device name: SUPRASSON P5 NEWTRON 510(k) number: K050895 Manufacturer: SATELEC-ACTEON Group 6. Indication for Use Statement The EndoPilot 2 systems are dental devices which… | 2005 |
What descends from it? (4)
3 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?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K233865 (Dentsply Sirona, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · ELC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELC
104in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELC
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELC
284in 2025
MAUDE reports naming product code ELC, 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 | 6 | 92 | 0 | 12 |
| 2008 | 4 | 216 | 0 | 58 |
| 2009 | 4 | 121 | 0 | 108 |
| 2010 | 4 | 201 | 0 | 79 |
| 2011 | 3 | 122 | 0 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 13 | 174 | 0 | 6 |
| 2014 | 6 | 193 | 0 | 37 |
| 2015 | 5 | 150 | 0 | 135 |
| 2016 | 3 | 88 | 0 | 169 |
| 2017 | 2 | — | 0 | 356 |
| 2018 | 1 | — | 0 | 289 |
| 2019 | 4 | 192 | 0 | 302 |
| 2020 | 1 | — | 0 | 164 |
| 2021 | 3 | 196 | 0 | 166 |
| 2022 | 2 | — | 2 | 165 |
| 2023 | 5 | 258 | 0 | 210 |
| 2024 | 4 | 104 | 0 | 219 |
| 2025 | 2 | — | 0 | 284 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EndoPilot 2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.
The EndoPilot 2 is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K202906: EndoPilot2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202906
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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