# K141504: T-8000 Therozone Unit

- Pathway: 510(k) (Traditional)
- Applicant: Therozone USA, Inc.
- Decided: Feb 24, 2015 after 263 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 K964796 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991946: Ultra-Kleen Powder for Dental Unit Water Lines, Models 513P, 505L, Sterilex Corp. (1999) Summary page 4.
- K964796: Odyssey I Dental Water Unit, Germiphene Corp. (1997) Summary page 4.

## Indications for use
The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.

Source page: https://510kreport.com/device/K141504
Methodology: https://510kreport.com/methodology