510(k) · Cleared
ClearedUltrasonic Endo Activation Device (Model:Actor I pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Bomedent Medical Technology Co.,Ltd · ELC Scaler, Ultrasonic
Cleared on Sep 8, 2022 as substantially equivalent to K202906 (Schlumbohm GmbH & Co. KG, 2021) after a 265-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Sep 8, 2022
- Review
- 265 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K971350 (1997). 15 ancestors in all, the oldest K942139 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 6 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 5 generations backK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
- 4 generations backK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
- 3 generations backK133298 Endo SmartMeta Biomed, Inc. · 2014
- 2 generations backK153285 EMS-200Meta Systems Co., Ltd. · 2016
- 1 generation backK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- This deviceK213947 Ultrasonic Endo Activation Device (Model:Actor I pro)Changzhou Bomedent Medical Technology Co.,Ltd · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −6 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −5 | K092412 | Strong Implant Handpieces | Saeshin Precision Co., Ltd. | 2009 | — |
| −4 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011 | — |
| −3 | K133298 | Endo Smart | Meta Biomed, Inc. | 2014 | — |
| −2 | K153285 | EMS-200 | Meta Systems Co., Ltd. | 2016 | — |
| −1 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K202906 | EndoPilot2Summary page 4…aler Regulation Class: Class II Panel: Dental Product Code: ELC 3. Predicate Device 510(K) number: K202906 Device Name: EndoPilot2 Manufacturer: Schlumbohm GmbH & Co. KG Common name… | 2021 |
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 25 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 15 ancestors has a recall.
- 2 other devices also cite its predicate K202906.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for root-
canal cleaning and preparation.
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended 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/K213947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213947: Ultrasonic Endo Activation Device (Model:Actor I pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213947
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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