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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K260830
Device Name APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
Applicant
Sangi Co., Ltd.
3-11-6 Tsukiji, Chuo-Ku
Tokyo,  JP 104-8440
Applicant Contact Tetsuya Yoshioka
Correspondent
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison,  NJ  07940
Correspondent Contact Dave Yungvirt
Regulation Number872.3260
Classification Product Code
LBH  
Date Received03/13/2026
Decision Date 03/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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