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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 K191865
Device Name SmartLite Pro Modular LED Curing Light
Applicant
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Karl Nittinger
Correspondent
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Karl Nittinger
Regulation Number872.6070
Classification Product Code
EBZ  
Subsequent Product Code
NTK  
Date Received07/12/2019
Decision Date 11/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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