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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Amalgam
510(k) Number K223182
Device Name Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy
Applicant
Worldwork S.R.L
Via Del Progresso, 47
Montebello,  IT 36054
Applicant Contact Daniela Baldissera
Correspondent
Worldwork S.R.L
Via Del Progresso, 47
Montebello,  IT 36054
Correspondent Contact Daniela Baldissera
Regulation Number872.3070
Classification Product Code
OIV  
Subsequent Product Code
EJJ  
Date Received10/11/2022
Decision Date 05/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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