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FDA 510(k) Application Details - K042199
Device Classification Name
Activator, Ultraviolet, For Polymerization
More FDA Info for this Device
510(K) Number
K042199
Device Name
Activator, Ultraviolet, For Polymerization
Applicant
HERAEUS KULZER GMBH
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND, IN 46614-2517 US
Other 510(k) Applications for this Company
Contact
CHERYL V ZIMMERMAN
Other 510(k) Applications for this Contact
Regulation Number
872.6070
More FDA Info for this Regulation Number
Classification Product Code
EBZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2004
Decision Date
09/08/2004
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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