FDA 510(k) Applications for Medical Device Product Code "OIV"
(Dental Amalgam)

FDA 510(k) Number Applicant Device Name Decision Date
K140125 NEW STETIC NEW STETIC DENTAL AMALGAM ALLOY 04/29/2014
K081273 SDI LTD. ULTRACAPS S 07/10/2008
K223182 WorldWork S.R.L 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 05/01/2023


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