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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name composite resin warmer
510(k) Number K182017
Device Name Compex HD
Applicant
AdDent, Inc.
43 Miry Brook Road
Danbury,  CT  06810
Applicant Contact Joshua Friedman
Correspondent
AdDent, Inc.
43 Miry Brook Road
Danbury,  CT  06810
Correspondent Contact Joshua Friedman
Regulation Number872.6100
Classification Product Code
QGO  
Date Received07/27/2018
Decision Date 04/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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