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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
Predetermined Change
Control Plan Authorized		 No
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