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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 K102538
Device Name ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI
Applicant
JYOTI CERAMIC INDUSTRIES PRIVATE LIMITED
C-21, NICE, SATPUR
nashik, maharashtra,  IN 422007
Applicant Contact raju merani
Correspondent
JYOTI CERAMIC INDUSTRIES PRIVATE LIMITED
C-21, NICE, SATPUR
nashik, maharashtra,  IN 422007
Correspondent Contact raju merani
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/03/2010
Decision Date 10/27/2010
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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