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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
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