510(k) · Cleared
ClearedEds Ultrasonic Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Essential Dental Systems, Inc. · ELC Scaler, Ultrasonic
Cleared on Jan 22, 2014 as substantially equivalent to K960889 (San Diego Swiss Machining, Inc., 1996) after a 155-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Jan 22, 2014
- Review
- 155 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960889 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK960889 Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod.…San Diego Swiss Machining, Inc. · 1996
- This deviceK132609 Eds Ultrasonic TipsEssential Dental Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK182145 tün® ultrasonic tips product familyEngineered Endodontics · 2019
Most influential descendants
Showing 1 of 1 · See all- K182145tün® ultrasonic tips product familyEngineered Endodontics · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960889 | Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod.… | San Diego Swiss Machining, Inc. | 1996 | — |
| 0 (this device) | K132609 | Eds Ultrasonic Tips | Essential Dental Systems, Inc. | 2014 | — |
| +1 | K182145 | tün® ultrasonic tips product family | Engineered Endodontics | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K960889 | Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod.…Summary page 1…CFR Number: 872.4850 Device class: Class 11 Product Code: ELC 3. Predicate Device Information: 1. Sapphire Plus@ Tips, San Diego Swiss Machining, K960889. 4. Device Description: EDS Ultrasonic Tips are an accessory to a piezoelectric ultrasonic handpiece and scaler… | 1996 |
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 |
|---|---|---|---|
| K182145 | tün® ultrasonic tips product family | 2019 | 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?
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
EDS Ultrasonic Tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132609: Eds Ultrasonic Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132609
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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