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FDA 510(k) Application Details - K122892
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K122892
Device Name
Resin, Root Canal Filling
Applicant
AVALON BIOMED INC.
7282 55TH AVE E #227
BRADENTON, FL 34203 US
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Contact
CAROLYN PRIMUS
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Regulation Number
872.3820
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Classification Product Code
KIF
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More FDA Info for this Product Code
Date Received
09/20/2012
Decision Date
12/11/2012
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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