# K031461: Carrier Tips

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Aug 5, 2003 after 89 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
Used to deliver ProRootB MTA Material in surgical and non-surgical dental applications in conjunction with an ultrasonic unit.

Source page: https://510kreport.com/device/K031461
Methodology: https://510kreport.com/methodology