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FDA 510(k) Application Details - K112967
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K112967
Device Name
Crown And Bridge, Temporary, Resin
Applicant
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
VOLCJA DRAGA 42
VOLCJA DRAGA 5293 SI
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Contact
JANJA LIPUSCEK
Other 510(k) Applications for this Contact
Regulation Number
872.3770
More FDA Info for this Regulation Number
Classification Product Code
EBG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/05/2011
Decision Date
08/28/2012
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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