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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 K153767
Device Name X-cera Zirconia Blanks
Applicant
Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.
2~4th Floor, 1st Bldg., S. Industrial Park Of Honghual
South Industrial Park Of Honghualing, Nanshan District
Shenzhen,  CN
Applicant Contact YONGQING CHEN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/30/2015
Decision Date 03/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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