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FDA 510(k) Application Details - K032892
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
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510(K) Number
K032892
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVENUE
YORK, PA 17404 US
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Contact
P. JEFFERY LEHN
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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
09/17/2003
Decision Date
09/26/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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