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FDA 510(k) Application Details - K063062
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K063062
Device Name
Agent, Tooth Bonding, Resin
Applicant
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND, IN 46614 US
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Contact
CHERYL V ZIMMERMAN
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Regulation Number
872.3200
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Classification Product Code
KLE
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More FDA Info for this Product Code
Date Received
10/05/2006
Decision Date
12/01/2006
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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