FDA 510(k) Application Details - K223182

Device Classification Name Dental Amalgam

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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
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Regulation Number 872.3070

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Classification Product Code OIV
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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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