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FDA 510(k) Application Details - K102538
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K102538
Device Name
Powder, Porcelain
Applicant
JYOTI CERAMIC INDUSTRIES PRIVATE LIMITED
C-21, NICE, SATPUR
NASHIK, MAHARASHTRA 422007 IN
Other 510(k) Applications for this Company
Contact
RAJU MERANI
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/2010
Decision Date
10/27/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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