510(k) · Cleared
ClearedAei DR. Terauchi Ultrasonic Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Eagle Instruments, Inc. · ELC Scaler, Ultrasonic
Cleared on Mar 29, 2013 as substantially equivalent to K960889 (San Diego Swiss Machining, Inc., 1996) after a 225-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 29, 2013
- Review
- 225 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960889 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960889 Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod.…San Diego Swiss Machining, Inc. · 1996
- This deviceK122501 Aei DR. Terauchi Ultrasonic TipsAmerican Eagle Instruments, Inc. · 2013
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) | K122501 | Aei DR. Terauchi Ultrasonic Tips | American Eagle Instruments, Inc. | 2013 | — |
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…EDICATE DEVICE: Company Device 510(k) No. Date Cleared DENTSPLY ProUltra® Endo Tips K960889 May 10, 1996 (a.k.a Sapphire Pius®Tips) DEVICE DESCRIPTION: The AEI Ultrasonic Tips are an… | 1996 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K960889.
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 AEI Dr. Terauchi Ultrasonic Tips are intended for use by dental professionals for endodontic root preparation procedures. The Ultrasonic Tips can remove soft and hard tissue from a narrow dentinal structure in order to make space for permanent filling material in the canal. They can also assist in the removal of separated instruments or other intra-canal blockages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122501: Aei DR. Terauchi 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/K122501
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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