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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 K253461
Device Name Demi Pro
Applicant
Meta Systems Co., Ltd.
#1214-18, Sicox Tower 12f, 484, Dunchon-Daero, Jungwon-Gu
Seongnam-Si,  KR 13229
Applicant Contact Ray Jeon
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received10/07/2025
Decision Date 10/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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