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FDA 510(k) Application Details - K190930
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K190930
Device Name
Crown And Bridge, Temporary, Resin
Applicant
Parkell, Inc.
300 Executive Drive
Edgewood, NY 11717 US
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Contact
David Mott
Other 510(k) Applications for this Contact
Regulation Number
872.3770
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Classification Product Code
EBG
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More FDA Info for this Product Code
Date Received
04/10/2019
Decision Date
09/05/2019
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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