510(k) · Cleared
ClearedAdvanced Endodontic System- Designer Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asi Medical, Inc. · ELC Scaler, Ultrasonic
Cleared on Mar 28, 2013 after a 174-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 28, 2013
- Review
- 174 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2i134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system arid water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.
The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123139 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123139: Advanced Endodontic System- Designer Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123139
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026