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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
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