# K100606: Vatea Endontic Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Redent Nova, Ltd.
- Decided: May 28, 2010 after 86 days
- Product code: NYL (Handpiece, Air-Powered, Root Canal Irrigation)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K991035 (1999). 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)
- K991035: Quantec-E Irrigation System, Sybron Dental Specialties, Inc. (1999) Summary page 1.

## Indications for use
The VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.

Source page: https://510kreport.com/device/K100606
Methodology: https://510kreport.com/methodology