510(k) · Cleared
ClearedSonic Air MM1500 + (Mid), Model 50400014
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Mega Societe Anonyme · ELC Scaler, Ultrasonic
Cleared on Aug 10, 2009 after a 462-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Aug 10, 2009
- Review
- 462 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK081268 Sonic Air MM1500 + (Mid), Model 50400014Micro-Mega Societe Anonyme · 2009
- Descendant · cites it directly · 3 of its ownK130025 Sonendo Endotherapy SystemSonendo, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK133752 Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean…Sonendo, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK143448 Sonendo GentleWave SystemSonendo, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK233844 OdneCleanOdne AG · 2024
- Descendant · cites it directly · 0 of its ownK171150 AW-100Micron Corporation · 2018
Most influential descendants
Showing 5 of 5 · See all- K130025Sonendo Endotherapy SystemSonendo, Inc. · 2013 · cites it directly3descendants
- K133752Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar Procedure KitSonendo, Inc. · 2014 · cites it directly2descendants
- K143448Sonendo GentleWave SystemSonendo, Inc. · 2015 · 2 generations on1descendant
- K233844OdneCleanOdne AG · 2024 · 3 generations on0descendants
- K171150AW-100Micron Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081268 | Sonic Air MM1500 + (Mid), Model 50400014 | Micro-Mega Societe Anonyme | 2009 | — |
| +1 | K130025 | Sonendo Endotherapy System | Sonendo, Inc. | 2013 | — |
| +1 | K133752 | Sonendo Omniclean Endotherpay System Console, Sonendo Omniclean Molar… | Sonendo, Inc. | 2014 | — |
| +2 | K143448 | Sonendo GentleWave System | Sonendo, Inc. | 2015 | — |
| +3 | K233844 | OdneClean | Odne AG | 2024 | — |
| +1 | K171150 | AW-100 | Micron Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 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, K130025 (Sonendo, Inc., 2013) has gone furthest, with 3 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. 2009, 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?
Endodontics
- canal preparation
- canal cleaning
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081268: Sonic Air MM1500 + (Mid), Model 50400014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081268
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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