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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 K093571
Device Name ZR DENTAL BLOCK
Applicant
AMS CO., LTD
#708 LE-MEILLEUR TOWN
837-19 GANGNAM-GU
SEOUL,  KR 135-937
Applicant Contact CLAUDE YANG
Correspondent
AMS CO., LTD
#708 LE-MEILLEUR TOWN
837-19 GANGNAM-GU
SEOUL,  KR 135-937
Correspondent Contact CLAUDE YANG
Regulation Number872.6660
Classification Product Code
EIH  
Date Received11/18/2009
Decision Date 03/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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