# K991946: Ultra-Kleen Powder for Dental Unit Water Lines, Models 513P, 505L

- Pathway: 510(k) (Traditional)
- Applicant: Sterilex Corp.
- Decided: Sep 3, 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
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
- K141504: T-8000 Therozone Unit (2015), 0 descendants of its own

## Indications for use
This product has been specially formulated and clinically proven to clean deposits and control bacterial contamination in Dental Unit Water Lines.

Source page: https://510kreport.com/device/K991946
Methodology: https://510kreport.com/methodology