KATANA Cleaner, KATANA Cleaner (Trial)
K-Number: K191133 · 2019-10-08
ApplicantKuraray Noritake Dental, Inc.
Decision Date2019-10-08
Product CodePME
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
KATANA Cleaner, KATANA Cleaner (Trial) is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2019-10-08 under approval number K191133. The device is classified under product code PME. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KATANA Cleaner, KATANA Cleaner (Trial)?
KATANA Cleaner, KATANA Cleaner (Trial) is a medical device that received FDA 510(k) clearance on 2019-10-08. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K191133.
When was KATANA Cleaner, KATANA Cleaner (Trial) approved by the FDA?
KATANA Cleaner, KATANA Cleaner (Trial) received FDA 510(k) clearance on 2019-10-08, under approval number K191133.
What company makes KATANA Cleaner, KATANA Cleaner (Trial)?
KATANA Cleaner, KATANA Cleaner (Trial) is manufactured by Kuraray Noritake Dental, Inc..
What is the FDA product code for KATANA Cleaner, KATANA Cleaner (Trial)?
The FDA product code for KATANA Cleaner, KATANA Cleaner (Trial) is PME.
Related Clinical Trials
Other Devices by Kuraray Noritake Dental, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.