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FDA 510(k) Application Details - K060293
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K060293
Device Name
Crown And Bridge, Temporary, Resin
Applicant
DENTSPLY INTERNATIONAL, INC.
SUSQUEHANNA COMMERCE CTR., 221
W. PHILADELPHIA ST., SUITE 60
YORK, PA 17404 US
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Contact
HELEN LEWIS
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Regulation Number
872.3770
More FDA Info for this Regulation Number
Classification Product Code
EBG
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More FDA Info for this Product Code
Date Received
02/06/2006
Decision Date
02/17/2006
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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