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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 K182947
Device Name Dental Pain Eraser
Applicant
Synapse Dental, LLC
67B Phenix Avenue
Cranston,  RI  02920
Applicant Contact Cosmo Haralambidis
Correspondent
Experien Group, LLC
224 Airport Parkway, Suite 250
San Jose,  CA  95110
Correspondent Contact Valerie Defiesta-Ng
Classification Product Code
LWM  
Date Received10/23/2018
Decision Date 03/26/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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