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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K201492
Device Name Non-Sterile Zirconia Block
Applicant
Bioden Co., Ltd.
#B-803 119, Gasan Digital 1-Ro, Geumcheon-Gu, Korea
Seoul,  KR
Applicant Contact MyeongEun Song
Correspondent
Med.Com
1809 Holland Dr.
Somerset,  NJ  08873
Correspondent Contact Chris Park
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/04/2020
Decision Date 03/10/2021
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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