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FDA 510(k) Application Details - K113431
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K113431
Device Name
Powder, Porcelain
Applicant
BETTINI S.P.A.
110 E. GRANADA
BLVD. SUITE 207
ORMOND BEACH, FL 32176 US
Other 510(k) Applications for this Company
Contact
Claude Berthoin
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
11/21/2011
Decision Date
03/30/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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