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FDA 510(k) Application Details - K051006
Device Classification Name
Agent, Tooth Bonding, Resin
More FDA Info for this Device
510(K) Number
K051006
Device Name
Agent, Tooth Bonding, Resin
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
872.3200
More FDA Info for this Regulation Number
Classification Product Code
KLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/20/2005
Decision Date
06/07/2005
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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