510(k) · Cleared

Cleared

KATANA Cleaner, KATANA Cleaner (Trial)

K191133510(k) TraditionalCleared Oct 8, 2019162-day reviewClass II21 CFR 872.3260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kuraray Noritake Dental, Inc. · PME External Cleaning Solution

Cleared on Oct 8, 2019 as substantially equivalent to K925375 (Ultradent Products, Inc., 1993) after a 162-day review. Its family tree reaches back 1 generation to 1993.

Decided: Oct 8, 2019
Review: 162 days
Class: Class II
Product code: PME
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925375 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK925375 Consepsis ScrubUltradent Products, Inc. · 1993
This deviceK191133 KATANA Cleaner, KATANA Cleaner (Trial)Kuraray Noritake Dental, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925375	Consepsis Scrub	Ultradent Products, Inc.	1993	—
0 (this device)	K191133	KATANA Cleaner, KATANA Cleaner (Trial)	Kuraray Noritake Dental, Inc.	2019	—

FIG. 1 — Lineage of K191133, 1993–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PME? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K925375	Consepsis Scrub Summary page 5 …Page: 2 of 7 4.Predicate Device 1) CONSEPSIS 510(k) Number K925375 Classification: Cavity Varnish Pr…	Ultradent Products, Inc.	1993	—
†	K163171	CeraClean	Bisco, Inc.	2017	—
†	K990040	Clearfil SE Bond	Kuraray Co.	1999	—
†	K042913	Clearfil Tri-S Bond	Kuraray Medical, Inc.	2004	—
†	K133078	K-Etchant Syringe; Needle Tip (E)	Kuraray Noritake Dental, Inc.	2013	—
†	K033938	Clearfil Protect Bond	Kuraray Medical, Inc.	2004	—

Also cleared against K925375: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
3 other devices also cite its predicate K925375.

How does its category compare?

All PME devices

PME External Cleaning Solution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · PME

1in 2019

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PME

Too few PME 510(k)s in any year since 2007 to give a median.

Recalls per year · PME

No recall names PME since 2007.

Adverse event reports per year · PME

No MAUDE report names PME since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	1	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

[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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K191133 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191133: KATANA Cleaner, KATANA Cleaner (Trial).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191133

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026