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FDA 510(k) Application Details - K020347
Device Classification Name
Alloy, Gold-Based Noble Metal
More FDA Info for this Device
510(K) Number
K020347
Device Name
Alloy, Gold-Based Noble Metal
Applicant
WIELAND EDELMETALLE GMBH & CO.
SCHWENNINGER STRABE 13
PFORZHEIM D-75179 DE
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Contact
GERHARD POLZER
Other 510(k) Applications for this Contact
Regulation Number
872.3060
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Classification Product Code
EJT
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More FDA Info for this Product Code
Date Received
02/04/2002
Decision Date
04/24/2002
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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