# K122501: Aei DR. Terauchi Ultrasonic Tips

- Pathway: 510(k) (Traditional)
- Applicant: American Eagle Instruments, Inc.
- Decided: Mar 29, 2013 after 225 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960889 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960889: Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod. 300117 Tips, San Diego Swiss Machining, Inc. (1996) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K122501
Methodology: https://510kreport.com/methodology