# K191133: KATANA Cleaner, KATANA Cleaner (Trial)

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Oct 8, 2019 after 162 days
- Product code: PME (External Cleaning Solution)
- Device class: 2
- Regulation: 21 CFR 872.3260
- 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 K925375 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925375: Consepsis Scrub, Ultradent Products, Inc. (1993) Summary page 5.

## Indications for use
[1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in. [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment

Source page: https://510kreport.com/device/K191133
Methodology: https://510kreport.com/methodology