510(k) · Cleared
ClearedScorpion Ultrasonic Scaling Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scorpion · ELC Scaler, Ultrasonic
Cleared on Jul 14, 2006 as substantially equivalent to K033764 (Satelec, 2004) and 2 other predicates after a 204-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Jul 14, 2006
- Review
- 204 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K942139 (1995). 9 ancestors in all, the oldest K896749 (1990). No later device cites it as a predicate yet.
- 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 deviceK053578 Scorpion Ultrasonic Scaling InsertsScorpion · 2006
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) | K053578 | Scorpion Ultrasonic Scaling Inserts | Scorpion | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K033764 | SP Newtron ModuleSummary page 1…caling insert Classification name: Ultrasonic scaler Legallymarketeddevices towitchequivalence is claimed: SATELEC #1 insert, accessory of SP NEWTRON module (K033764) from SATELEC -EMS "A" insert, accessory of EMS KERMIT® (K992504) from EMS - Sapphire Plus® Tips (K960889)… | 2004 |
| * | K992504 | Ems KermitSummary page 1…s towitchequivalence is claimed: SATELEC #1 insert, accessory of SP NEWTRON module (K033764) from SATELEC -EMS "A" insert, accessory of EMS KERMIT® (K992504) from EMS - Sapphire Plus® Tips (K960889) from SAN DIEGO Swiss Machining, Theproductanditsintended use: The… | 2000 |
| * | K960889 | Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod.…Summary page 1…#1 insert, accessory of SP NEWTRON module (K033764) from SATELEC -EMS "A" insert, accessory of EMS KERMIT® (K992504) from EMS - Sapphire Plus® Tips (K960889) from SAN DIEGO Swiss Machining, Theproductanditsintended use: The Scorpion ultrasonic scaling inserts are used by d… | 1996 |
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 11 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 9 ancestors has a recall.
- 4 other devices also cite its predicate K033764.
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?
Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from the teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053578: Scorpion Ultrasonic Scaling Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053578
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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