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FDA 510(k) Application Details - K080182
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K080182
Device Name
Crown And Bridge, Temporary, Resin
Applicant
WIELAND DENTAL + TECHNIK GMBH & CO. KG
SCHWENNINGER STRABE 13
PFORZHEIM D-75179 DE
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Contact
GERHARD POLZER
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
01/25/2008
Decision Date
04/08/2008
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
FDA Source Information for K080182
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