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FDA 510(k) Application Details - K111668
Device Classification Name
Liner, Cavity, Calcium Hydroxide
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510(K) Number
K111668
Device Name
Liner, Cavity, Calcium Hydroxide
Applicant
NEO DENTAL CHEMICAL PRODUCTS CO., LTD.
611 WEST 5TH STREET
AUSTIN, TX 78701 US
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Contact
ROBERT SEIPLE
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Regulation Number
872.3250
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Classification Product Code
EJK
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More FDA Info for this Product Code
Date Received
06/14/2011
Decision Date
08/19/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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