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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 K141724
Device Name UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK
Applicant
Liaoning Upcera Co., Ltd.
853 Dorchester Ln., Suite-B
New Milford,  NJ  07646
Applicant Contact CHARLES SHEN
Correspondent
Liaoning Upcera Co., Ltd.
853 Dorchester Ln., Suite-B
New Milford,  NJ  07646
Correspondent Contact CHARLES SHEN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/26/2014
Decision Date 10/22/2014
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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