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FDA 510(k) Application Details - K150432
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K150432
Device Name
Crown And Bridge, Temporary, Resin
Applicant
UNION DENTAL S.A.
PASEO DE LA ESTACION, 4.
TIELMES 28550 ES
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Contact
JOSE LUIS RODRIGUEZ BLANCO
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Regulation Number
872.3770
More FDA Info for this Regulation Number
Classification Product Code
EBG
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More FDA Info for this Product Code
Date Received
02/19/2015
Decision Date
08/14/2015
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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