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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 K220419
Device Name Apapro Desensitizer
Applicant
Sangi Co, Ltd.
3-11-6 Tsukiji, Chuo-Ku
Tokyo,  JP 104-8440
Applicant Contact Douglas Mercadante
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.3260
Classification Product Code
LBH  
Date Received02/14/2022
Decision Date 02/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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