FDA.reportPublic FDA data

510(k) K233285

Device
KATANA Zirconia ONE For IMPLANT
Applicant
Kuraray Noritake Dental, Inc.
510(k) number
K233285
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-24
Date received
2023-09-29
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
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
Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-Ku JP 100-0004 100-0004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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