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FDA 510(k) Application Details - K063626
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K063626
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
COSMETIC DENTAL MATERIALS INC
812 WATER ST. N.E.
ALBANY, OR 97321 US
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Contact
ROBERT BOWERS
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Regulation Number
872.3760
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Classification Product Code
EBI
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More FDA Info for this Product Code
Date Received
12/06/2006
Decision Date
02/08/2007
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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