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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
Mtech Group
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
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