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510(k) K191133

Device
KATANA Cleaner, KATANA Cleaner (Trial)
Applicant
Kuraray Noritake Dental Inc.
510(k) number
K191133
Product code
PME  
Decision
Substantially Equivalent (SESE)
Decision date
2019-10-08
Date received
2019-04-29
Regulation
872.3260
Classification name
External Cleaning Solution
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yasujiro Ohara
Address
Ote Center Bldg. 7f Chiyoda-Ku JP 100-0004 100-0004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163171CeraCleanBisco, Inc.2017-04-14
K152322Resolve 2.0Denali Corporation2015-12-16

Legacy Summary#

summary

FDA Review#

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