# K964271: Ign 500 TM Water Cleaning Unit with Calbenium Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Airel-West
- Decided: Dec 19, 1997 after 420 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K990479: Hygeniclear WKR 1, Water-Delivery Device Ultraclear (1999), 0 descendants of its own

## Indications for use
Intended to help prevent gross contamination of the dental operatory unit.

Source page: https://510kreport.com/device/K964271
Methodology: https://510kreport.com/methodology