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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K180065
Device Name FUSION Plus Curing Light
Applicant
DentLight Inc.
1825 Summit Ave. Ste 210
Plano,  TX  75074
Applicant Contact Richard Liu
Correspondent
DentLight Inc.
1825 Summit Ave. Ste 210
Plano,  TX  75074
Correspondent Contact Richard Liu
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/09/2018
Decision Date 04/19/2019
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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