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FDA 510(k) Application Details - K124025
Device Classification Name
Varnish, Cavity
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510(K) Number
K124025
Device Name
Varnish, Cavity
Applicant
DENTAL TECHNOLOGIES, INC.
6901 NORTH HAMLIN AVE.
LINCOLNWOOD, IL 60712 US
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Contact
PAULA ERICKSON
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Regulation Number
872.3260
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Classification Product Code
LBH
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More FDA Info for this Product Code
Date Received
12/28/2012
Decision Date
09/18/2013
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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