# K991035: Quantec-E Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Jun 24, 1999 after 87 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Micro SWP Sterile Water Pump: named in the summary without a submission number

## Most influential descendants
- K100606: Vatea Endontic Irrigation System (2010), 0 descendants of its own

## Indications for use
The Quantec-E Irrigation System is a self-contained, fluid delivery unit consisting of a pump unit console, irrigation reservoirs and tubing intended to be used in dentistry to provide irrigation while using the dental handpieces attached to the Quantec-E Endo System.

Source page: https://510kreport.com/device/K991035
Methodology: https://510kreport.com/methodology