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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 K191221
Device Name Cybird LED Curing Light
Applicant
Dxm Co., Ltd.
Baekseok-Dong, Ilsan Technotown 1003, 138, Ilsan-Ro,
Ilsandong-Gu
Goyang-Si,  KR 411-360
Applicant Contact Seung Hyun Kim
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received05/07/2019
Decision Date 01/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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