Dental Pain Eraser

Device, Electrical Dental Anesthesia

Synapse Dental

The following data is part of a premarket notification filed by Synapse Dental with the FDA for Dental Pain Eraser.

Pre-market Notification Details

Device IDK192429
510k NumberK192429
Device Name:Dental Pain Eraser
ClassificationDevice, Electrical Dental Anesthesia
Applicant Synapse Dental 67 Phenix Avenue Cranston,  RI  02910
ContactCosmo Haralambidis
CorrespondentValerie Defiesta-ng
Experien Group, LLC 224 Airport Parkawy, Suite 250 San Jose,  CA  95110
Product CodeLWM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-05
Decision Date2020-01-14

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