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FDA 510(k) Application Details - K140125
Device Classification Name
Dental Amalgam
More FDA Info for this Device
510(K) Number
K140125
Device Name
Dental Amalgam
Applicant
NEW STETIC
445 APOLLO BEACH BLVD
APOLLO BEACH, FL 33572 US
Other 510(k) Applications for this Company
Contact
JOHN O'BRIEN
Other 510(k) Applications for this Contact
Regulation Number
872.3070
More FDA Info for this Regulation Number
Classification Product Code
OIV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/16/2014
Decision Date
04/29/2014
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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