Cleared Traditional

KATANA Cleaner, KATANA Cleaner (Trial)

K191133 · Kuraray Noritake Dental, Inc. · Dental

Oct 2019

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K191133 is an FDA 510(k) clearance for the KATANA Cleaner, KATANA Cleaner (Trial), a External Cleaning Solution (Class II — Special Controls, product code PME), submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on October 8, 2019, 162 days after receiving the submission on April 29, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K191133 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2019
Decision Date	October 08, 2019
Days to Decision	162 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	PME — External Cleaning Solution
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3260
Definition	For Use On Dental Restorations, External To The Mouth, Prior To Insertion Into The Mouth.