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FDA 510(k) Application Details - K132230
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K132230
Device Name
Powder, Porcelain
Applicant
ZIRKONZAHN SRL
67 MAIN STREET
SILVER CREEK, NY 14136 US
Other 510(k) Applications for this Company
Contact
DONNA M HARTNETT
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
07/18/2013
Decision Date
11/05/2014
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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