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FDA 510(k) Application Details - K112186
Device Classification Name
Crown And Bridge, Temporary, Resin
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510(K) Number
K112186
Device Name
Crown And Bridge, Temporary, Resin
Applicant
BIOLOREN SRL
VIA ALESSANDRO VOLTA 59
SARONNO -- IT
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Contact
ANDREA RATTI
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Regulation Number
872.3770
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Classification Product Code
EBG
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More FDA Info for this Product Code
Date Received
07/29/2011
Decision Date
11/08/2011
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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