510(k) · Cleared
ClearedSP Newtron Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · ELC Scaler, Ultrasonic
Cleared on Mar 1, 2004 as substantially equivalent to K972026 (Satelec, 1997) after a 90-day review. Its family tree reaches back 3 generations to 1995. 20 later devices descend from it.
- Decided
- Mar 1, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942139 (1995). 20 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK942139 Suprasson P MaxSatelec · 1995
- 2 generations backK961158 Suprasson P5 BoosterSatelec · 1996
- 1 generation backK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- This deviceK033764 SP Newtron ModuleSatelec · 2004
- Descendant · cites it directly · 11 of its ownK050895 Surpasson P5 NewtronSatelec · 2005
- Descendant · 2 generations on · 4 of its ownK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- Descendant · cites it directly · 3 of its ownK102218 Compact Piezo P2K, PowercareMectron S.P.A. · 2011
- Descendant · 2 generations on · 2 of its ownK140965 Multipiezo Pro, MultipiezoMectron S.P.A. · 2014
- Descendant · 2 generations on · 2 of its ownK071424 Pmax Newtron XSSatelec - Acteon Group · 2007
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K050895Surpasson P5 NewtronSatelec · 2005 · cites it directly11descendants
- K202906EndoPilot2Schlumbohm GmbH & Co. KG · 2021 · 2 generations on4descendants
- K102218Compact Piezo P2K, PowercareMectron S.P.A. · 2011 · cites it directly3descendants
- K140965Multipiezo Pro, MultipiezoMectron S.P.A. · 2014 · 2 generations on2descendants
- K071424Pmax Newtron XSSatelec - Acteon Group · 2007 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942139 | Suprasson P Max | Satelec | 1995 | — |
| −2 | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| −1 | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| 0 (this device) | K033764 | SP Newtron Module | Satelec | 2004 | — |
| +1 | K050895 | Surpasson P5 Newtron | Satelec | 2005 | — |
| +2 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| +1 | K102218 | Compact Piezo P2K, Powercare | Mectron S.P.A. | 2011 | — |
| +2 | K140965 | Multipiezo Pro, Multipiezo | Mectron S.P.A. | 2014 | — |
| +2 | K071424 | Pmax Newtron XS | Satelec - Acteon Group | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K972026 | SP4044 & SP4055 Lux ModulesSummary page 1…dentification of Predicate Devices The SP NEWTRON module is substantially equivalent to its predicate devices, SP 40:55 and SP 4055 LUX Modules (K972026) from SATELEC previously cleared and currently marketed. D. Device Description The SP NEWTRON is… | 1997 |
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050895 | Surpasson P5 Newtron | 2005 | 11 |
| K102218 | Compact Piezo P2K, Powercare | 2011 | 3 |
| K233922 | SP Newtron Can-a; Module Newtron Can-a Emb; Support Xinetic; NWT Can Slim Led Cord G3… | 2024 | 1 |
| K140990 | Ems Piezon 707 Bik and Piezon 707 Bik Led | 2015 | 0 |
| K053578 | Scorpion Ultrasonic Scaling Inserts | 2006 | 0 |
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 9 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050895 (Satelec, 2005) has gone furthest, with 11 descendants of its own.
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?
Scaling
* Interdental junction treatment
* Tooth neck and subgingival treatment
* Treatment of large deposits
* Treatment of coating and tobacco stains
* Interproximal treatment
* Prosthesis conservative/restorative:
o Inlay/onlay condensation
o Amalgam plugging
o Loosening prostheses (bridge, crown, post, pivot...)
Endodontia:
* Canal preparation
* Canal cleaning
* Canal filling
* Gutta percha condensation
* Treatment resumption
* Retro surgery
* Micro retro surgery
* Surface smoothing after burring
Periodontia:
* Root planing
* Initial therapy
* Treatment of periodontal pockets
* Treatment of furcations
* Maintenance therapy
* Implant maintenance
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033764: SP Newtron Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033764
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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