510(k) · Cleared
ClearedUltrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · ELC Scaler, Ultrasonic
Cleared on Feb 19, 1987 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 19, 1987
- Review
- 59 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK864996 Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30Dentsply Intl. · 1987
- Descendant · cites it directly · 4 of its ownK970123 Dentsply Cavitron SPS Scaler SystemDentsply Intl. · 1997
- Descendant · cites it directly · 4 of its ownK970342 Cavitron Jet with SPS SystemDentsply Intl. · 1997
- Descendant · 2 generations on · 2 of its ownK052334 Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model…Dentsply Intl. · 2005
- Descendant · 2 generations on · 2 of its ownK014188 New Prophy PowderDentsply Intl. · 2002
- Descendant · 3 generations on · 1 of its ownK021450 Clinpro Prophy Powder3M Espe AG Dental Products · 2002
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K970123Dentsply Cavitron SPS Scaler SystemDentsply Intl. · 1997 · cites it directly4descendants
- K970342Cavitron Jet with SPS SystemDentsply Intl. · 1997 · cites it directly4descendants
- K052334Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131Dentsply Intl. · 2005 · 2 generations on2descendants
- K014188New Prophy PowderDentsply Intl. · 2002 · 2 generations on2descendants
- K021450Clinpro Prophy Powder3M Espe AG Dental Products · 2002 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864996 | Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30 | Dentsply Intl. | 1987 | — |
| +1 | K970123 | Dentsply Cavitron SPS Scaler System | Dentsply Intl. | 1997 | — |
| +1 | K970342 | Cavitron Jet with SPS System | Dentsply Intl. | 1997 | — |
| +2 | K052334 | Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131 | Dentsply Intl. | 2005 | — |
| +2 | K014188 | New Prophy Powder | Dentsply Intl. | 2002 | — |
| +3 | K021450 | Clinpro Prophy Powder | 3M Espe AG Dental Products | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
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?
- Of its descendants, K970123 (Dentsply Intl., 1997) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K864996 · printed Nov 5, 2026
Cite this page
510(k) Report. “K864996: Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K864996
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026