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FDA 510(k) Application Details - K991442
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K991442
Device Name
Material, Tooth Shade, Resin
Applicant
S & C POLYMER GMBH
ROBERT-BOSCH-STR. 5
D-25335
ELMSHORN DE
Other 510(k) Applications for this Company
Contact
JURGEN ENGELBRECHT
Other 510(k) Applications for this Contact
Regulation Number
872.3690
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Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/26/1999
Decision Date
06/03/1999
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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