510(k) · Cleared
ClearedNewtron P5, Newtron P5 B.Led
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 Mar 10, 2014 as substantially equivalent to K050895 (Satelec, 2005) and 2 other predicates after a 231-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Mar 10, 2014
- Review
- 231 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K942139 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK942139 Suprasson P MaxSatelec · 1995
- 5 generations backK961158 Suprasson P5 BoosterSatelec · 1996
- 4 generations backK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- 3 generations backK033764 SP Newtron ModuleSatelec · 2004
- 2 generations backK050895 Surpasson P5 NewtronSatelec · 2005
- 1 generation backK071424 Pmax Newtron XSSatelec - Acteon Group · 2007
- This deviceK132267 Newtron P5, Newtron P5 B.LedSatelec - Acteon Group · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942139 | Suprasson P Max | Satelec | 1995 | — |
| −5 | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| −4 | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| −3 | K033764 | SP Newtron Module | Satelec | 2004 | — |
| −2 | K050895 | Surpasson P5 Newtron | Satelec | 2005 | — |
| −1 | K071424 | Pmax Newtron XS | Satelec - Acteon Group | 2007 | — |
| 0 (this device) | K132267 | Newtron P5, Newtron P5 B.Led | Satelec - Acteon Group | 2014 | — |
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? (3)
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…Date Cleared Code number 1 SUPRASSON P5 NIEWTIRON SATELEC ELO K050895 April 20, 2005 2 ProUltra Piezo Ultrasonic SATELEC ELO K113430 February 23, 201… | 2005 |
| * | K113430 | Proultra Piezo UltrasonicSummary page 2…UPRASSON P5 NIEWTIRON SATELEC ELO K050895 April 20, 2005 2 ProUltra Piezo Ultrasonic SATELEC ELO K113430 February 23, 2012 3 PMAX NIEWTIRON XS SATELEC ELC K071424 August 24, 200… | 2012 |
| * | K071424 | Pmax Newtron XSSummary page 2…ProUltra Piezo Ultrasonic SATELEC ELO K113430 February 23, 2012 3 PMAX NIEWTIRON XS SATELEC ELC K071424 August 24, 2007 04 - Description of the Device The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New… | 2007 |
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 19 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 7 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. 2014, 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?
This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132267 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132267: Newtron P5, Newtron P5 B.Led.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132267
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