510(k) · Cleared
ClearedSuprasson P5 Booster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · ELC Scaler, Ultrasonic
Cleared on May 23, 1996 as substantially equivalent to K942139 (Satelec, 1995) after a 62-day review. Its family tree reaches back 1 generation to 1995. 26 later devices descend from it.
- Decided
- May 23, 1996
- Review
- 62 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942139 (1995). 26 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK942139 Suprasson P MaxSatelec · 1995
- This deviceK961158 Suprasson P5 BoosterSatelec · 1996
- Descendant · cites it directly · 21 of its ownK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- Descendant · 2 generations on · 20 of its ownK033764 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 · 3 generations on · 3 of its ownK102218 Compact Piezo P2K, PowercareMectron S.P.A. · 2011
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K972026SP4044 & SP4055 Lux ModulesSatelec · 1997 · cites it directly21descendants
- K033764SP Newtron ModuleSatelec · 2004 · 2 generations on20descendants
- K050895Surpasson P5 NewtronSatelec · 2005 · cites it directly11descendants
- K202906EndoPilot2Schlumbohm GmbH & Co. KG · 2021 · 2 generations on4descendants
- K102218Compact Piezo P2K, PowercareMectron S.P.A. · 2011 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942139 | Suprasson P Max | Satelec | 1995 | — |
| 0 (this device) | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| +1 | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| +2 | K033764 | SP Newtron Module | Satelec | 2004 | — |
| +1 | K050895 | Surpasson P5 Newtron | Satelec | 2005 | — |
| +2 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
| +3 | K102218 | Compact Piezo P2K, Powercare | Mectron S.P.A. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K942139 | Suprasson P MaxSummary page 1…ry Name: SUPRASSON PS5 Booster C. ldentification of Predicate Device(s) The SUPRASSON PS5 Booster is substantially equivalent to its predicate device, SUPRASSON P-MAX (K942139), previously cleared and currently marketed. D. Device Description The SUPRASSON PS5 Booster ultrasonic scaler consists of thre… | 1995 |
What descends from it? (26)
See all 266 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972026 | SP4044 & SP4055 Lux Modules | 1997 | 21 |
| K050895 | Surpasson P5 Newtron | 2005 | 11 |
| K070866 | Asc-12 Piezoelectric Scaler | 2007 | 0 |
| K053178 | Symmetry S-Series Piezoelectric Scaling Tips | 2006 | 0 |
| K033198 | Apoza Ultrasonic Scaler and Edodontics Unit, Selector U2 | 2004 | 0 |
| K994299 | Art-P3, Model P3-1-Art-A1 | 2000 | 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?
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?
The SUPRASSON P-Max and SUPRASSON P5 are intended to provide overall
prophylaxis and preservation of soft and hard tissue during the 3 standard dental treatments;
Scaling, Periodontics, and Endodontics.
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/K961158 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961158: Suprasson P5 Booster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961158
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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