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FDA 510(k) Application Details - K043170
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K043170
Device Name
Agent, Tooth Bonding, Resin
Applicant
HARRY J. BOSWORTH CO.
7227 NORTH HAMLIN AVE.
SKOKIE, IL 60076 US
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Contact
MILDRED M GOLDSTEIN
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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
11/16/2004
Decision Date
02/25/2005
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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