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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 K233518
Device Name BASE290 LED Curing Light
Applicant
Handpiece Headquarters
620 S. Placentia Avenue
Placentia,  CA  92870
Applicant Contact Frederick Wang
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received11/01/2023
Decision Date 11/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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