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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 K190112
Device Name Non-Sterile Zirconia Block
Applicant
Fine Advanced Compound Co., Ltd.
7, Galgot-Gil, Jinwi-Myeon
Pyeongtaek,  KR
Applicant Contact Jeong Kwang-Ho
Correspondent
Med.Com
1809 Holland Dr.
Somerset,  NJ  08873
Correspondent Contact Chris Park
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/23/2019
Decision Date 12/20/2019
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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