Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Device, Electrical Dental Anesthesia
510(k) Number K192429
Device Name Dental Pain Eraser
Applicant
Synapse Dental
67 Phenix Ave.
Cranston,  RI  02910
Applicant Contact Cosmo Haralambidis
Correspondent
Experien Group, LLC
224 Airport Parkawy
Suite 250
San Jose,  CA  95110
Correspondent Contact Valerie Defiesta-NG
Classification Product Code
LWM  
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
Predetermined Change
Control Plan Authorized		 No
-
-