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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Cleaning Solution
510(k) Number K191133
Device Name KATANA Cleaner, KATANA Cleaner (Trial)
Applicant
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f
Chiyoda-Ku,  JP 100-0004
Applicant Contact Yasujiro Ohara
Correspondent
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f
Chiyoda-Ku,  JP 100-0004
Correspondent Contact Yasujiro Ohara
Regulation Number872.3260
Classification Product Code
PME  
Subsequent Product Code
LBH  
Date Received04/29/2019
Decision Date 10/08/2019
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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