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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 COURTYARD 7
ZONE 2 WANGSIYING INDUSTRIAL BASE, CHAOYANG DISTRICT
BEIJING,  CN 100023
Applicant Contact N/A N/A
Correspondent
PROMY CHEMICAL, INC.
130 TRAVALINI COURT
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
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