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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 K161652
Device Name DIAZIR
Applicant
Zxtgy (Beijing) Technology Co., Ltd.
132 Jingchen Runye Ct.yard 7
Zone 2 Wangsiying Industrial Base, Chaoyang District
Beijing,  CN 100023
Applicant Contact N/A N/A
Correspondent
Promy Chemical, Inc.
130 Travalini Ct.
El Sobrante,  CA  94803
Correspondent Contact JOHN G. HUANG
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/15/2016
Decision Date 11/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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