510(k) · Cleared
ClearedCavitron Jet with SPS 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 4, 1997 as substantially equivalent to K864996 (Dentsply Intl., 1987) after a 65-day review. Its family tree reaches back 1 generation to 1987. 4 later devices descend from it.
- Decided
- Apr 4, 1997
- Review
- 65 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 deviceK970342 Cavitron Jet with SPS SystemDentsply Intl. · 1997
- Descendant · cites it directly · 2 of its ownK014188 New Prophy PowderDentsply Intl. · 2002
- Descendant · 2 generations on · 1 of its ownK021450 Clinpro Prophy Powder3M Espe AG Dental Products · 2002
- Descendant · cites it directly · 0 of its ownK130862 Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK063236 Beta-PowderBrainbase Corporation · 2007
Most influential descendants
Showing 4 of 4 · See all- K014188New Prophy PowderDentsply Intl. · 2002 · cites it directly2descendants
- K021450Clinpro Prophy Powder3M Espe AG Dental Products · 2002 · 2 generations on1descendant
- K130862Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc. · 2013 · cites it directly0descendants
- K063236Beta-PowderBrainbase Corporation · 2007 · 2 generations on0descendants
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) | K970342 | Cavitron Jet with SPS System | Dentsply Intl. | 1997 | — |
| +1 | K014188 | New Prophy Powder | Dentsply Intl. | 2002 | — |
| +2 | K021450 | Clinpro Prophy Powder | 3M Espe AG Dental Products | 2002 | — |
| +1 | K130862 | Cavitron Prophy-Jet Air Polishing Prophylaxis System | Dentsply Intl., Inc. | 2013 | — |
| +2 | K063236 | Beta-Powder | Brainbase Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2007 | 1 | 0 |
| 2013 | 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…DATE PREPARED: January 28, 1997 TRADE NAME: CAVITRON™ JET WITH SPS SYSTEM CLASSIFICATION NAME: Ultrasonic Scaler 21 CFR, 872.4850 PREDICATE DEVICE: CAVITRON® JET SCALER K864996 DESCRIPTION: The CAVITRON™ JET WITH SPS SYSTEM is a portable stand alone multi- functional prophylaxis unit. It has two operatin… | 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 CAVITRON™ JET WITH SPS SYSTEM is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. This CAVITRON™ JET WITH SPS SYSTEM is used to debride 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/K970342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970342: Cavitron Jet with SPS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970342
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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