KATANA Cleaner, KATANA Cleaner (Trial)

FDA 510(k) K191133 · Kuraray Noritake Dental, Inc.

Substantially Equivalent

510(k) numberK191133

Submission

Device name
KATANA Cleaner, KATANA Cleaner (Trial)
Applicant
Kuraray Noritake Dental, Inc.
Chiyoda-Ku, JP
Received
April 29, 2019
Decision date
October 8, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PME – External Cleaning Solution
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3260
Specialty
Dental

For use on dental restorations, external to the mouth, prior to insertion into the mouth.

Other 510(k)s with product code PME

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K163171CeraCleanPME · Traditional Bisco, Inc.04/14/2017SE
K152322Resolve 2.0PME · Traditional Denali Corporation12/16/2015SE

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Questions and answers

When was KATANA Cleaner, KATANA Cleaner (Trial) cleared by the FDA?

KATANA Cleaner, KATANA Cleaner (Trial) (K191133) received a 510(k) decision of Substantially Equivalent on October 8, 2019, 162 days after the submission was received.

What is the product code of K191133?

The FDA product code is PME – External Cleaning Solution, a Class II (moderate risk) device regulated under 21 CFR 872.3260.