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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K190139
Device Name Zircos-Com
Applicant
Bioden Co., Ltd.
#B-803 119, Gasan Digital 1-Ro, Geumcheon-Gu
Seoul,  KR 08589
Applicant Contact Kim Hye Min
Correspondent
Med.Com
1809 Holland Dr.
Somerset,  NJ  08873
Correspondent Contact Chris Park
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/29/2019
Decision Date 04/24/2020
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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