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FDA 510(k) Application Details - K050331
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K050331
Device Name
Agent, Tooth Bonding, Resin
Applicant
SOUTHERN DENTAL INDUSTRIES, INC.
729 N. ROUTE 83, SUITE 315
BENSENVILLE, IL 60106 US
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Contact
SAMANTHA J CHEETHAM
Other 510(k) Applications for this Contact
Regulation Number
872.3200
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Classification Product Code
KLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2005
Decision Date
03/24/2005
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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