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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K233285
Device Name KATANA Zirconia ONE For IMPLANT
Applicant
Kuraray Noritake Dental, Inc.
Tokiwabashi Tower, 2-6-4, Otemachi
Chiyoda-Ku,  JP 100-0004
Applicant Contact Yasujiro Ohara
Correspondent
Kuraray Noritake Dental, Inc.
Tokiwabashi Tower, 2-6-4, Otemachi
Chiyoda-Ku,  JP 100-0004
Correspondent Contact Yasujiro Ohara
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/29/2023
Decision Date 05/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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