510(k) · Cleared
ClearedSurpasson P5 Newtron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · ELC Scaler, Ultrasonic
Cleared on Apr 20, 2005 as substantially equivalent to K961158 (Satelec, 1996) and 1 other predicate after a 12-day review. Its family tree reaches back 4 generations to 1995. 11 later devices descend from it.
- Decided
- Apr 20, 2005
- Review
- 12 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K942139 (1995). 11 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK942139 Suprasson P MaxSatelec · 1995
- 3 generations backK961158 Suprasson P5 BoosterSatelec · 1996
- 2 generations backK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- 1 generation backK033764 SP Newtron ModuleSatelec · 2004
- This deviceK050895 Surpasson P5 NewtronSatelec · 2005
- Descendant · cites it directly · 4 of its ownK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- Descendant · cites it directly · 2 of its ownK071424 Pmax Newtron XSSatelec - Acteon Group · 2007
- Descendant · 2 generations on · 1 of its ownK233865 X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK251811 Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK242317 Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K202906EndoPilot2Schlumbohm GmbH & Co. KG · 2021 · cites it directly4descendants
- K071424Pmax Newtron XSSatelec - Acteon Group · 2007 · cites it directly2descendants
- K233865X-Smart Pro; X-Smart Pro+Dentsply Sirona, Inc. · 2024 · 2 generations on1descendant
- K251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc. · 2025 · 3 generations on0descendants
- K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942139 | Suprasson P Max | Satelec | 1995 | — |
| −3 | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| −2 | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| −1 | K033764 | SP Newtron Module | Satelec | 2004 | — |
| 0 (this device) | K050895 | Surpasson P5 Newtron | Satelec | 2005 | — |
| +1 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| +1 | K071424 | Pmax Newtron XS | Satelec - Acteon Group | 2007 | — |
| +2 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024 | — |
| +3 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025 | — |
| +2 | K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2021 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K961158 | Suprasson P5 BoosterSummary page 1…Devices The SUPRASSON P5 NEWTRON is substantially equivalent to its predicate devices, SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K0033764) from SATELEC previously cleared and currently marketed.… | 1996 |
| * | K033764 | SP Newtron ModuleSummary page 1…6, including the technology of the SP NEWTRON module which received 510(k) clearance for dental applications (K033764) on March 1, 2004. The SUPRASSON P5 NEWTRON maintains all the functions and the key components of t… | 2004 |
What descends from it? (11)
See all 117 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 10 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202906 (Schlumbohm GmbH & Co. KG, 2021) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K961158.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Periodontics
Endodontics
Scaling
Prosthesis
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/K050895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050895: Surpasson P5 Newtron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050895
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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