510(k) · Cleared
ClearedSP4044 & SP4055 Lux Modules
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · ELC Scaler, Ultrasonic
Cleared on Jul 9, 1997 as substantially equivalent to K961158 (Satelec, 1996) after a 37-day review. Its family tree reaches back 2 generations to 1995. 21 later devices descend from it.
- Decided
- Jul 9, 1997
- Review
- 37 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942139 (1995). 21 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK942139 Suprasson P MaxSatelec · 1995
- 1 generation backK961158 Suprasson P5 BoosterSatelec · 1996
- This deviceK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- Descendant · cites it directly · 20 of its ownK033764 SP Newtron ModuleSatelec · 2004
- Descendant · 2 generations on · 11 of its ownK050895 Surpasson P5 NewtronSatelec · 2005
- Descendant · 3 generations on · 4 of its ownK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
- Descendant · 2 generations on · 3 of its ownK102218 Compact Piezo P2K, PowercareMectron S.P.A. · 2011
- Descendant · 3 generations on · 2 of its ownK140965 Multipiezo Pro, MultipiezoMectron S.P.A. · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K033764SP Newtron ModuleSatelec · 2004 · cites it directly20descendants
- K050895Surpasson P5 NewtronSatelec · 2005 · 2 generations on11descendants
- K202906EndoPilot2Schlumbohm GmbH & Co. KG · 2021 · 3 generations on4descendants
- K102218Compact Piezo P2K, PowercareMectron S.P.A. · 2011 · 2 generations on3descendants
- K140965Multipiezo Pro, MultipiezoMectron S.P.A. · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942139 | Suprasson P Max | Satelec | 1995 | — |
| −1 | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| 0 (this device) | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| +1 | K033764 | SP Newtron Module | Satelec | 2004 | — |
| +2 | K050895 | Surpasson P5 Newtron | Satelec | 2005 | — |
| +3 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| +2 | K102218 | Compact Piezo P2K, Powercare | Mectron S.P.A. | 2011 | — |
| +3 | K140965 | Multipiezo Pro, Multipiezo | Mectron S.P.A. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K961158 | Suprasson P5 BoosterSummary page 1…55 LUX Modules C. ldentification of Predicate Device(s) The SP 4055 and SP 4055 LUX Modules are substantially equivalent to its predicate device, SUPRASSON P5 Booster (K961158) previously cleared and currently marketed. D. Device Description The SP 4055 and SP 4055 LUX modules are sub-assemblies of the… | 1996 |
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033764 | SP Newtron Module | 2004 | 20 |
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?
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 Endodontics Periodontics Please refer to the attached listing for a complete description. Scaling: Interdental junction treatment Tooth neck and subgingival treatment Treatment of large deposits Treatment of coatings and tobacco stains Treatment of periodontal pockets Interproximal treatment Retro Surgery Plugging Amalgam plugging Loosening Prosthesis Loosening (crown, pivot locsening) Inlay/Onlay Condensation: Finish of inlay/onlay restorations…
Read the full statement (105 words)
Scaling
Endodontics
Periodontics
Please refer to the attached listing for a complete description.
Scaling:
Interdental junction treatment
Tooth neck and subgingival treatment
Treatment of large deposits
Treatment of coatings and tobacco stains
Treatment of periodontal pockets
Interproximal treatment
Retro Surgery
Plugging
Amalgam plugging
Loosening
Prosthesis Loosening (crown, pivot locsening)
Inlay/Onlay Condensation:
Finish of inlay/onlay restorations
Endodontia:
Canal preparation
Canal cleaning
Canal filling
Treatment resumption
Prosthesis:
Preparing in luted denture
Surface smoothing after burring
Micro Retro Surgery
Gutta Condensation:
Treatment resumption on gutta percha
Post loosening
Silver cone loosening
Gutta percha condensation
Periodontia:
$Xeot planing
Initial therapy
Treatment of periodontal pockets
Treatiment of furcations
Maintenancs therapy
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/K972026 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972026: SP4044 & SP4055 Lux Modules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972026
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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