510(k) · Cleared
ClearedCavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · ELC Scaler, Ultrasonic
Cleared on Sep 2, 2005 as substantially equivalent to K970123 (Dentsply Intl., 1997) after a 7-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- Sep 2, 2005
- Review
- 7 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864996 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK864996 Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30Dentsply Intl. · 1987
- 1 generation backK970123 Dentsply Cavitron SPS Scaler SystemDentsply Intl. · 1997
- This deviceK052334 Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model…Dentsply Intl. · 2005
- Descendant · cites it directly · 0 of its ownK150535 Cavitron Touch Ultrasonic Scaling SystemDentsply International, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK130862 Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864996 | Ultrasonic Scaler 3000/ Prophy-Jet 30/ Cavi-Jet 30 | Dentsply Intl. | 1987 | — |
| −1 | K970123 | Dentsply Cavitron SPS Scaler System | Dentsply Intl. | 1997 | — |
| 0 (this device) | K052334 | Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131 | Dentsply Intl. | 2005 | — |
| +1 | K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | 2015 | — |
| +1 | K130862 | Cavitron Prophy-Jet Air Polishing Prophylaxis System | Dentsply Intl., Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K970123 | Dentsply Cavitron SPS Scaler SystemSummary page 1…Ultrasonic scaler 872.4850 PREDICATE DEVICESI DENTSPLY Cavitron SPS Scaler System, Model G-119 (K970123) of the Cavitron RF DEVICE DESCRIPTION: The Modified… | 1997 |
What descends from it? (2)
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?
- The line of descent spans 18 years and passes through 1 company; a new generation was cleared every 10.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150535 (Dentsply International, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K970123.
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?
Used for ultrasonic procedures:
* All general supra and subgingival scaling applications
* Periodontal debridement for all types of periodontal diseases
* Endodontic procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052334: Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052334
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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