# K990479: Hygeniclear WKR 1, Water-Delivery Device Ultraclear

- Pathway: 510(k) (Traditional)
- Applicant: Hygenitek, Inc.
- Decided: May 13, 1999 after 86 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
Longest line of descent: 1 generation back to K882491 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971278: Pure Company Fluid Delivery System, Pure Co. (1997) Summary page 1.
- K971727: Dci Water Purifier, Dental Components, Inc. (1997) Summary page 1.
- K964271: Ign 500 TM Water Cleaning Unit with Calbenium Liquid, Airel-West (1997) Summary page 1.
- K882491: Cutting Fluid System for Dental High Speed Drills, Steri-Sol, Inc. (1988) Summary page 1.
- K973765: BIO-2000, Micrylium Laboratories (1998) Summary page 1.

## Indications for use
To isolate water delivery lines in the dental operatory unit and reduce the contamination due to biofilm to improve the quality of water supplied to dental handpieces and other dental instruments.

Source page: https://510kreport.com/device/K990479
Methodology: https://510kreport.com/methodology