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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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