# K992195: Quantec-E Irrigation System 2

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Oct 8, 1999 after 101 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Quantec-E Irrigation System: named in the summary without a submission number

## Indications for use
The Quantec-E Irrigation System 2 is an AC-powered, 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/K992195
Methodology: https://510kreport.com/methodology