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FDA 510(k) Application Details - K180578
Device Classification Name
Crown And Bridge, Temporary, Resin
More FDA Info for this Device
510(K) Number
K180578
Device Name
Crown And Bridge, Temporary, Resin
Applicant
Harvest Dental Products, LLC
905 Columbia Street
Brea, CA 92821 US
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Contact
Sasha Der Avanessian
Other 510(k) Applications for this Contact
Regulation Number
872.3770
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Classification Product Code
EBG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/05/2018
Decision Date
12/12/2018
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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