510(k) · Cleared
ClearedDentsply Cavitron SPS Scaler System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · ELC Scaler, Ultrasonic
Cleared on Apr 11, 1997 as substantially equivalent to K864996 (Dentsply Intl., 1987) after an 87-day review. Its family tree reaches back 1 generation to 1987. 4 later devices descend from it.
- Decided
- Apr 11, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864996 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK864996 Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30Dentsply Intl. · 1987
- This deviceK970123 Dentsply Cavitron SPS Scaler SystemDentsply Intl. · 1997
- Descendant · cites it directly · 2 of its ownK052334 Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model…Dentsply Intl. · 2005
- Descendant · 2 generations on · 0 of its ownK150535 Cavitron Touch Ultrasonic Scaling SystemDentsply International, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK130862 Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc. · 2013
- Descendant · cites it directly · 0 of its ownK100401 Swerv Magnetostrictive Ultrasonic Scaler SystemHu-Friedy Mfg. Co., Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K052334Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131Dentsply Intl. · 2005 · cites it directly2descendants
- K150535Cavitron Touch Ultrasonic Scaling SystemDentsply International, Inc. · 2015 · 2 generations on0descendants
- K130862Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc. · 2013 · 2 generations on0descendants
- K100401Swerv Magnetostrictive Ultrasonic Scaler SystemHu-Friedy Mfg. Co., Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864996 | Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30 | Dentsply Intl. | 1987 | — |
| 0 (this device) | K970123 | Dentsply Cavitron SPS Scaler System | Dentsply Intl. | 1997 | — |
| +1 | K052334 | Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131 | Dentsply Intl. | 2005 | — |
| +2 | K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | 2015 | — |
| +2 | K130862 | Cavitron Prophy-Jet Air Polishing Prophylaxis System | Dentsply Intl., Inc. | 2013 | — |
| +1 | K100401 | Swerv Magnetostrictive Ultrasonic Scaler System | Hu-Friedy Mfg. Co., Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K864996 | Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30Summary page 1…997 TRADE NAME: DENTSPLY® CAVITRON® SPS SCALER SYSTEM CLASSIFICATION NAME: Ultrasonic Scaler 21 CFR, 872.4850 PREDICATE DEVICE: CAVITRON® MODEL 3000™ ULTRASONIC SCALER K864996 DESCRIPTION: The SPS SCALER is a portable stand alone ultrasonic scaler. It operates with a fine, warm water spray, easily and e… | 1987 |
What descends from it? (4)
2 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?
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 SPS SCALER SYSTEM is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. This SPS SCALER SYSTEM is used with scaling tips and a fine warm water spray for debriding light to heavy calculus and plaque deposits from tooth and root surfaces.
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/K970123 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970123: Dentsply Cavitron SPS Scaler System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970123
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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