FDA 510(k) Applications Submitted by Mauro Malzyner

FDA 510(k) Number Submission Date Device Name Applicant
K160086 01/15/2016 SHOFU Enamel Conditioner SHOFU DENTAL CORPORATION
K200470 02/26/2020 Shofu Block HC Hard Shofu Dental Corporation
K160596 03/02/2016 BEAUTIFIL II LS SHOFU DENTAL CORPORATION
K180649 03/13/2018 BeautiCem Veneer Kit Shofu Dental Corporation
K180803 03/28/2018 BeautiBond Universal Shofu Dental Corporation
K181496 06/07/2018 VINTAGE PRO Shofu Dental Corporation
K151700 06/24/2015 BEAUTIFIL II Gingiva SHOFU DENTAL CORPORATION
K191794 07/03/2019 Vintage Art Universal Shofu Dental Corporation
K161891 07/11/2016 HC Primer Shofu Dental Corporation
K172106 07/12/2017 SHOFU MZ Primer Plus Shofu Dental Corporation
K222253 07/27/2022 GlasIonomer FX ULTRA Shofu Dental Corporation
K162261 08/11/2016 CERAMAGE UP SHOFU DENTAL CORPORATION
K172530 08/21/2017 BEAUTIFIL Flow Plus X Shofu Dental Corporation
K152392 08/24/2015 VINTAGE LD SHOFU DENTAL CORPORATION
K152451 08/28/2015 VINTAGE Art LF SHOFU DENTAL CORPORATION
K212939 09/15/2021 Vintage Prime Press Shofu Dental Corporation
K233161 09/27/2023 BeautiLink SA Shofu Dental Corporation
K182869 10/12/2018 Fit SA Shofu Dental Corporation
K163568 12/19/2016 SHOFU RESIN GLAZE Shofu Dental Corporation
K213965 12/20/2021 BeautiBond Xtreme Shofu Dental Corporation


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