510(k) · Cleared
ClearedSonendo GentleWave System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonendo, Inc. · ELC Scaler, Ultrasonic
Cleared on May 1, 2015 as substantially equivalent to K133752 (Sonendo, Inc., 2014) after a 150-day review. Its family tree reaches back 3 generations to 2009. 1 later device descends from it.
- Decided
- May 1, 2015
- Review
- 150 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K081268 (2009). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK081268 Sonic Air MM1500 + (Mid), Model 50400014Micro-Mega Societe Anonyme · 2009
- 2 generations backK130025 Sonendo Endotherapy SystemSonendo, Inc. · 2013
- 1 generation backK133752 Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean…Sonendo, Inc. · 2014
- This deviceK143448 Sonendo GentleWave SystemSonendo, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK233844 OdneCleanOdne AG · 2024
Most influential descendants
Showing 1 of 1 · See all- K233844OdneCleanOdne AG · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K081268 | Sonic Air MM1500 + (Mid), Model 50400014 | Micro-Mega Societe Anonyme | 2009 | — |
| −2 | K130025 | Sonendo Endotherapy System | Sonendo, Inc. | 2013 | — |
| −1 | K133752 | Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar… | Sonendo, Inc. | 2014 | — |
| 0 (this device) | K143448 | Sonendo GentleWave System | Sonendo, Inc. | 2015 | — |
| +1 | K233844 | OdneClean | Odne AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K133752 | Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure KitSummary page 4…rasonic Scaler Device Classification Class II per 21 CFR 872.4850 Product Code ELC Predicate Devices Primary: Sonendo OmniClean Endotherapy System (K133752) Reference: EMS Piezon Master 700 (K093000) Substantial Equivalence: The Sonendo GentleWave System is… | 2014 |
| † | K093000 | Ems Piezon Master 700 | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233844 | OdneClean | 2024 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K233844 (Odne AG, 2024) has gone furthest, with 0 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. 2015, this device’s year, is highlighted.
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 Sonendo GentleWave System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143448: Sonendo GentleWave System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143448
Report an extraction error
Are you the manufacturer?
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