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FDA 510(k) Application Details - K223182
Device Classification Name
Dental Amalgam
More FDA Info for this Device
510(K) Number
K223182
Device Name
Dental Amalgam
Applicant
WorldWork S.R.L
Via Del Progresso, 47
Montebello 36054 IT
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Contact
Daniela Baldissera
Other 510(k) Applications for this Contact
Regulation Number
872.3070
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Classification Product Code
OIV
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More FDA Info for this Product Code
Date Received
10/11/2022
Decision Date
05/01/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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