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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 K193570
Device Name Dental Pain Eraser
Applicant
Synapse Dental
67 Phenix Ave.
Cranston,  RI  02920
Applicant Contact Cosmo Haralambidis
Correspondent
Experien Group, LLC
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Valerie Defiesta-Ng
Classification Product Code
LWM  
Date Received12/23/2019
Decision Date 01/17/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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