# K132609: Eds Ultrasonic Tips

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Jan 22, 2014 after 155 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K182145: tün® ultrasonic tips product family (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K132609
Methodology: https://510kreport.com/methodology