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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, electrical dental anesthesia
510(k) Number K192429
Device Name Dental Pain Eraser
Synapse Dental
67 Phenix Avenue
Cranston,  RI  02910
Applicant Contact Cosmo Haralambidis
Experien Group, LLC
224 Airport Parkawy, Suite 250
San Jose,  CA  95110
Correspondent Contact Valerie Defiesta-NG
Classification Product Code
Date Received09/05/2019
Decision Date 01/14/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No