510(k) · Cleared
ClearedNewtron Booster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec - Acteon Group · ELC Scaler, Ultrasonic
Cleared on Nov 26, 2013 as substantially equivalent to K050895 (Satelec, 2005) and 1 other predicate after a 151-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Nov 26, 2013
- Review
- 151 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K942139 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK942139 Suprasson P MaxSatelec · 1995
- 4 generations backK961158 Suprasson P5 BoosterSatelec · 1996
- 3 generations backK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- 2 generations backK033764 SP Newtron ModuleSatelec · 2004
- 1 generation backK050895 Surpasson P5 NewtronSatelec · 2005
- This deviceK131997 Newtron BoosterSatelec - Acteon Group · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K942139 | Suprasson P Max | Satelec | 1995 | — |
| −4 | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| −3 | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| −2 | K033764 | SP Newtron Module | Satelec | 2004 | — |
| −1 | K050895 | Surpasson P5 Newtron | Satelec | 2005 | — |
| 0 (this device) | K131997 | Newtron Booster | Satelec - Acteon Group | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K050895 | Surpasson P5 NewtronSummary page 2…Trade Name Manufacturer Produc 510(kr Date Cleared SUPRASSON P5 NEWTRON SATELEC ELC K050895 April 20. 2005 ProUltra Piezo Ultrasonic SATELEC ELO 113430 February 23, 2012… | 2005 |
| * | K113430 | Proultra Piezo UltrasonicSummary page 2…ON P5 NEWTRON SATELEC ELC K050895 April 20. 2005 ProUltra Piezo Ultrasonic SATELEC ELO 113430 February 23, 2012 04 - Description of the Device… | 2012 |
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 18 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- 6 other devices also cite its predicate K050895.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131997: Newtron Booster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131997
Report an extraction error
Are you the manufacturer?
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