510(k) · Cleared
ClearedPmax Newtron XS
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 Aug 24, 2007 as substantially equivalent to K050895 (Satelec, 2005) after a 93-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 24, 2007
- Review
- 93 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K942139 (1995). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK071424 Pmax Newtron XSSatelec - Acteon Group · 2007
- Descendant · cites it directly · 0 of its ownK132322 Newtron P5 XS B.LedSatelec - Acteon Group · 2014
- Descendant · cites it directly · 0 of its ownK132267 Newtron P5, Newtron P5 B.LedSatelec - Acteon Group · 2014
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 |
|---|---|---|---|---|---|
| −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) | K071424 | Pmax Newtron XS | Satelec - Acteon Group | 2007 | — |
| +1 | K132322 | Newtron P5 XS B.Led | Satelec - Acteon Group | 2014 | — |
| +1 | K132267 | Newtron P5, Newtron P5 B.Led | Satelec - Acteon Group | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K050895 | Surpasson P5 NewtronSummary page 1…tion of Predicate Device Device Applicant 510(k) No. Date Cleared Suprasson® P5 Newtron Satelec K050895 April 20, 2005 The Satelec Pmax Newtron XS is substantially equivalent to the predicate device by Satelec, t… | 2005 |
What descends from it? (2)
2 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 12 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K132322 (Satelec - Acteon Group, 2014) has gone furthest, with 0 descendants of its own.
- 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. 2007, 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 Pmax Newtron XS is intended for use by qualified dental practitioners in the following dental applications: Periodontics Endodontics Scaling Prosthesis Please refer to the attached listing for a detailed description. Periodontics: Root planing Initial therapy Treatment of periodontal pockets Treatment of furcations Maintenance therapy Implant maintenance Endodontics: Canal preparation Canal cleaning Canal filling Gutta percha condensation Treatment…
Read the full statement (98 words)
The Pmax Newtron XS is intended for use by qualified dental practitioners in the following dental applications:
Periodontics
Endodontics
Scaling
Prosthesis
Please refer to the attached listing for a detailed description.
Periodontics:
Root planing
Initial therapy
Treatment of periodontal pockets
Treatment of furcations
Maintenance therapy
Implant maintenance
Endodontics:
Canal preparation
Canal cleaning
Canal filling
Gutta percha condensation
Treatment resumption
Retro Surgery
Micro Retro Surgery
Scaling (prophylaxis):
Interdental junction treatment
Tooth neck and subgingival treatment
Treatment of large deposits
Treatment of coating and tobacco stains
Interproximal treatment
Prosthesis (conservative/restorative):
Inlay/onlay condensation
Amalgam plugging
Loosening prostheses (bridge, crown, post, pivot...)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071424: Pmax Newtron XS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071424
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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