# K182145: tün® ultrasonic tips product family

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Endodontics
- Decided: Jun 7, 2019 after 303 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: 2 generations back to K960889 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132609: Eds Ultrasonic Tips, Essential Dental Systems, Inc. (2014) Summary page 4.

## Indications for use
tiin® 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/K182145
Methodology: https://510kreport.com/methodology