Mauro Malzyner

FDA Filings

This page includes the latest FDA filings for Mauro Malzyner. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011814610
FEI Number3011814610
NameMAURO MALZYNER
Owner & OperatorSHOFU INC.
Contact Address11 KAMITAKAMATSU-CHO FUKUINE, HIGASHIYAMA-KU
KYOTO JP-26 Kyoto 605-0983 JP
Official Correspondent
  • HISAAKI TACHIDOKORO
  • 81-7556-10411-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1225 STONE DR
San Marcos, CA 92078 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3012084997
FEI Number3012084997
NameMauro Malzyner
Owner & OperatorGATE DENTAL SERVICES LTD
Contact AddressGarrynagry Roscahill
Galway IE-G Galway none IE
Official Correspondent
  • PAUL MOORE
  • 353-87-6824551-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1225 Stone Dr
San Marcos, CA 92078 US
Establishment TypeManufacture Medical Device

Registration Number3006942526
FEI Number3006942526
NameMauro Malzyner
Owner & OperatorSHOFU INC.
Contact Address11 KAMITAKAMATSU-CHO FUKUINE, HIGASHIYAMA-KU
KYOTO JP-26 Kyoto 605-0983 JP
Official Correspondent
  • HISAAKI TACHIDOKORO
  • 81-7556-10411-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1225 Stone Drive
San Marcos, CA 92078 US
Establishment TypeManufacture Medical Device

Registration Number3002808149
FEI Number3002808149
NameMAURO MALZYNER
Owner & OperatorSHOFU INC.
Contact Address11 KAMITAKAMATSU-CHO FUKUINE, HIGASHIYAMA-KU
KYOTO JP-26 Kyoto 605-0983 JP
Official Correspondent
  • HISAAKI TACHIDOKORO
  • 81-7556-10411-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1225 STONE DR.
SAN MARCOS, CA 92078 US
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
MAURO MALZYNER [SHOFU INC.]
VINTAGE ART UNIVERSAL2019-10-17
MAURO MALZYNER [SHOFU INC.]
FIT SA2019-08-28
MAURO MALZYNER [SHOFU INC.]
BEAUTICEM VENEER KIT2019-06-13
MAURO MALZYNER [SHOFU INC.]
BEAUTICEM VENEER KIT2019-06-13
MAURO MALZYNER [SHOFU INC.]
VINTAGE PRO2018-12-19
MAURO MALZYNER [SHOFU INC.]
BEAUTIBOND UNIVERSAL2018-12-19
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL FLOW PLUS X2018-01-17
MAURO MALZYNER [SHOFU INC.]
SHOFU MZ Primer Plus2017-09-11
MAURO MALZYNER [SHOFU INC.]
SHOFU MZ Primer Plus2017-09-11
MAURO MALZYNER [SHOFU INC.]
SHOFU RESIN GLAZE2017-08-16
MAURO MALZYNER [SHOFU INC.]
HC PRIMER2017-02-03
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL II LS2017-02-03
MAURO MALZYNER [SHOFU INC.]
SHOFU ENAMEL CONDITIONER2017-02-03
MAURO MALZYNER [SHOFU INC.]
UNIVERSAL OXYBARRIER2017-01-11
MAURO MALZYNER [SHOFU INC.]
CERAMAGE UP2017-01-11
Mauro Malzyner [GATE DENTAL SERVICES LTD]
BurButler2016-09-22
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL II Gingiva2016-03-03
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL II Gingiva Pink Kit2016-03-03
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL II Gingiva PINK & Enamel WHITE Kit2016-03-03
MAURO MALZYNER [SHOFU INC.]
VINTAGE ART LF2016-01-15
MAURO MALZYNER [SHOFU INC.]
VINTAGE LD2016-01-15
MAURO MALZYNER [SHOFU INC.]
Beautifil II Gingiva PINK & Enamel WHITE Kit2016-01-11
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL II Enamel2016-01-11
MAURO MALZYNER [SHOFU INC.]
VERACIA2015-06-23
MAURO MALZYNER [SHOFU INC.]
VERACIA2015-06-23
MAURO MALZYNER [SHOFU INC.]
UNIVERSAL OPAQUE2015-02-05
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL E POSTERIOR2013-12-17
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL BULK2013-12-17
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL BULK FLOWABLE2013-10-25
MAURO MALZYNER [SHOFU INC.]
SHOFU DISK HC2013-10-25
MAURO MALZYNER [SHOFU INC.]
SHOFU DISK HC2013-10-25
MAURO MALZYNER [SHOFU INC.]
SHOFU BLOCK HC2013-10-25
MAURO MALZYNER [SHOFU INC.]
SHOFU BLOCK HC2013-10-25
MAURO MALZYNER [SHOFU INC.]
SHOFU DISK HC2013-10-25
MAURO MALZYNER [SHOFU INC.]
SHOFU DISK HC2013-10-25
MAURO MALZYNER [SHOFU INC.]
SHOFU BLOCK HC2013-10-25
MAURO MALZYNER [SHOFU INC.]
SHOFU BLOCK HC2013-10-25
MAURO MALZYNER [SHOFU INC.]
PRG BARRIER COAT2013-08-30
MAURO MALZYNER [SHOFU INC.]
VINTAGE MP PRESS OVER2013-05-30
MAURO MALZYNER [SHOFU INC.]
GLASIONOMER FX-II2013-01-08
MAURO MALZYNER [SHOFU INC.]
P&R Repair Kit2012-12-03
MAURO MALZYNER [SHOFU INC.]
Ceraresin Bond2012-12-03
MAURO MALZYNER [SHOFU INC.]
BEAUTICEM SA2012-08-01
MAURO MALZYNER [SHOFU INC.]
VERACIA SA2012-02-24
MAURO MALZYNER [SHOFU INC.]
VERACIA SA2012-02-24
MAURO MALZYNER [SHOFU INC.]
HY-BOND RESIGLASS2011-11-21
MAURO MALZYNER [SHOFU INC.]
BEAUTISEALANT2011-11-16
MAURO MALZYNER [SHOFU INC.]
IP TEMP CEMENT2011-11-16
MAURO MALZYNER [SHOFU INC.]
LITE ART2010-08-25
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL FLOW PLUS2010-08-25
MAURO MALZYNER [SHOFU INC.]
VINTAGE MP2010-04-28
MAURO MALZYNER [SHOFU INC.]
BEAUTIBOND2008-12-18
MAURO MALZYNER [SHOFU INC.]
VINTAGE ART2008-06-12
MAURO MALZYNER [SHOFU INC.]
RESICEM CEMENT2008-06-12
MAURO MALZYNER [SHOFU INC.]
LAB AIR Z HANDPIECE2008-06-11
MAURO MALZYNER [SHOFU INC.]
GLASIONOMER CEMENT CX-PLUS2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE HALO2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE HALO OPAQUE LIQUID-L 50mL2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE HALO MODEL LIQUID-L 50mL2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE HALO MODEL LIQUID-L 500mL2008-06-10
MAURO MALZYNER [SHOFU INC.]
ANTI-GREENING LIQUID2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE PORCELAIN2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE PAINT OPAQUE LIQUID - 50mL2008-06-10
MAURO MALZYNER [SHOFU INC.]
GLASIONOMER BASE CEMENT2008-06-10
MAURO MALZYNER [SHOFU INC.]
GLASIONOMER TYPE II CEMENT2008-06-10
MAURO MALZYNER [SHOFU INC.]
HY-BOND ZINC OXIDE TEMP CEMENT2008-06-10
MAURO MALZYNER [SHOFU INC.]
PORCELAIN STAIN POWDER2008-06-10
MAURO MALZYNER [SHOFU INC.]
HY-BOND ZINC PHOSPHATE CEMENT2008-06-10
MAURO MALZYNER [SHOFU INC.]
HY-BOND POLY CEMENT2008-06-10
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL OPAQUER2008-06-10
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL II2008-06-10
MAURO MALZYNER [SHOFU INC.]
FL BOND II2008-06-10
MAURO MALZYNER [SHOFU INC.]
FL BOND II2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE ZR2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE ZR UNI-LAYER2008-06-10
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL FLOW2008-06-10
MAURO MALZYNER [SHOFU INC.]
CERAMAGE2008-06-10
MAURO MALZYNER [SHOFU INC.]
M.L. PRIMER2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE LF2008-06-10
MAURO MALZYNER [SHOFU INC.]
VINTAGE AL2008-06-10
MAURO MALZYNER [SHOFU INC.]
BEAUTIFIL2008-06-10
MAURO MALZYNER [SHOFU INC.]
HY-BOND POLY TEMP CEMENT2008-06-10
MAURO MALZYNER [SHOFU INC.]
Solidex2008-06-09
MAURO MALZYNER [SHOFU INC.]
SHOFU COMPOSITE POLISHING PASTE2007-05-29
MAURO MALZYNER [SHOFU INC.]
INSTRUMENT, DIAMOND, DENTAL2003-10-06
MAURO MALZYNER [SHOFU INC.]
Condenser2003-10-06
Mauro Malzyner [SHOFU INC.]
ZILMASTER2003-10-06
Mauro Malzyner [SHOFU INC.]
THE ATTACHMENT REMOVAL KIT FOR CLEAR ALIGNERS2003-10-06
Mauro Malzyner [SHOFU INC.]
SUPERSNAP2003-10-06
Mauro Malzyner [SHOFU INC.]
SUPERGREENIE2003-10-06
Mauro Malzyner [SHOFU INC.]
SUPERBUFF2003-10-06
Mauro Malzyner [SHOFU INC.]
ONE GLOSS2003-10-06
Mauro Malzyner [SHOFU INC.]
LAB WHITE2003-10-06
Mauro Malzyner [SHOFU INC.]
LAB PINK2003-10-06
Mauro Malzyner [SHOFU INC.]
LAB CORAL2003-10-06
Mauro Malzyner [SHOFU INC.]
HARDIE2003-10-06
Mauro Malzyner [SHOFU INC.]
GREENIE2003-10-06
Mauro Malzyner [SHOFU INC.]
DURAWHITE2003-10-06
Mauro Malzyner [SHOFU INC.]
DURAGREEN2003-10-06
Mauro Malzyner [SHOFU INC.]
DURAGREEN FINE2003-10-06
Mauro Malzyner [SHOFU INC.]
COREMASTER2003-10-06
Mauro Malzyner [SHOFU INC.]
COMPOSITE2003-10-06
Mauro Malzyner [SHOFU INC.]
COMPOMASTER2003-10-06
Mauro Malzyner [SHOFU INC.]
CERAMISTE2003-10-06
Mauro Malzyner [SHOFU INC.]
CERAMISTE SOFT2003-10-06
Mauro Malzyner [SHOFU INC.]
CERAMASTER2003-10-06
Mauro Malzyner [SHOFU INC.]
BURBUTLER CADMASTER KIT2003-10-06
Mauro Malzyner [SHOFU INC.]
BURBUTLER ALL CERAMIC ABRASIVE KIT2003-10-06
Mauro Malzyner [SHOFU INC.]
BROWNIE2003-10-06
Mauro Malzyner [SHOFU INC.]
ACRYPOINT2003-10-06
MAURO MALZYNER [SHOFU INC.]
ZILMASTER2003-10-06
MAURO MALZYNER [SHOFU INC.]
THE ATTACHMENT REMOVAL KIT FOR CLEAR ALIGNERS2003-10-06
MAURO MALZYNER [SHOFU INC.]
SUPERSNAP2003-10-06
MAURO MALZYNER [SHOFU INC.]
SUPERGREENIE2003-10-06
MAURO MALZYNER [SHOFU INC.]
SUPERBUFF2003-10-06
MAURO MALZYNER [SHOFU INC.]
ONE GLOSS2003-10-06
MAURO MALZYNER [SHOFU INC.]
LAB WHITE2003-10-06
MAURO MALZYNER [SHOFU INC.]
LAB PINK2003-10-06
MAURO MALZYNER [SHOFU INC.]
LAB CORAL2003-10-06
MAURO MALZYNER [SHOFU INC.]
HARDIE2003-10-06
MAURO MALZYNER [SHOFU INC.]
GREENIE2003-10-06
MAURO MALZYNER [SHOFU INC.]
DURAWHITE2003-10-06
MAURO MALZYNER [SHOFU INC.]
DURAGREEN2003-10-06
MAURO MALZYNER [SHOFU INC.]
DURAGREEN FINE2003-10-06
MAURO MALZYNER [SHOFU INC.]
COREMASTER2003-10-06
MAURO MALZYNER [SHOFU INC.]
COMPOSITE2003-10-06
MAURO MALZYNER [SHOFU INC.]
COMPOMASTER2003-10-06
MAURO MALZYNER [SHOFU INC.]
CERAMISTE2003-10-06
MAURO MALZYNER [SHOFU INC.]
CERAMISTE SOFT2003-10-06
MAURO MALZYNER [SHOFU INC.]
CERAMASTER2003-10-06
MAURO MALZYNER [SHOFU INC.]
BURBUTLER CADMASTER KIT2003-10-06
MAURO MALZYNER [SHOFU INC.]
BURBUTLER ALL CERAMIC ABRASIVE KIT2003-10-06
MAURO MALZYNER [SHOFU INC.]
BROWNIE2003-10-06
MAURO MALZYNER [SHOFU INC.]
ACRYPOINT2003-10-06
Mauro Malzyner [SHOFU INC.]
THE ARTISTIC COMPOSITE KIT1996-01-02
Mauro Malzyner [SHOFU INC.]
ROBOT CARBIDE1996-01-02
MAURO MALZYNER [SHOFU INC.]
THE ARTISTIC COMPOSITE KIT1996-01-02
MAURO MALZYNER [SHOFU INC.]
ROBOT CARBIDE1996-01-02
MAURO MALZYNER [SHOFU INC.]
PRO ARCH1978-06-05
MAURO MALZYNER [SHOFU INC.]
HANDY IIM1978-06-05
Mauro Malzyner [SHOFU INC.]
ZILMASTER1978-06-05
Mauro Malzyner [SHOFU INC.]
SUPER-SNAP1978-06-05
Mauro Malzyner [SHOFU INC.]
SUPER-SNAP X-TREME STANDARD ULTRA-GLOSS PERFORMANCE KIT1978-06-05
Mauro Malzyner [SHOFU INC.]
SUPER-SNAP X-TREME MINI ULTRA-GLOSS PERFORMANCE KIT1978-06-05
Mauro Malzyner [SHOFU INC.]
SUMMADISK1978-06-05
Mauro Malzyner [SHOFU INC.]
LAB STONES1978-06-05
Mauro Malzyner [SHOFU INC.]
GREENIE1978-06-05
Mauro Malzyner [SHOFU INC.]
DURAGREEN1978-06-05
Mauro Malzyner [SHOFU INC.]
COREMASTER1978-06-05
Mauro Malzyner [SHOFU INC.]
CORAL STONES1978-06-05
Mauro Malzyner [SHOFU INC.]
COMPOMASTER1978-06-05
Mauro Malzyner [SHOFU INC.]
CHIPLESS WHEEL1978-06-05
Mauro Malzyner [SHOFU INC.]
CERAMISTE1978-06-05
Mauro Malzyner [SHOFU INC.]
CERAMASTER1978-06-05
Mauro Malzyner [SHOFU INC.]
BROWNIE1978-06-05
MAURO MALZYNER [SHOFU INC.]
ZILMASTER1978-06-05
MAURO MALZYNER [SHOFU INC.]
SUPER-SNAP1978-06-05
MAURO MALZYNER [SHOFU INC.]
SUPER-SNAP X-TREME STANDARD ULTRA-GLOSS PERFORMANCE KIT1978-06-05
MAURO MALZYNER [SHOFU INC.]
SUPER-SNAP X-TREME MINI ULTRA-GLOSS PERFORMANCE KIT1978-06-05
MAURO MALZYNER [SHOFU INC.]
SUMMADISK1978-06-05
MAURO MALZYNER [SHOFU INC.]
LAB STONES1978-06-05
MAURO MALZYNER [SHOFU INC.]
GREENIE1978-06-05
MAURO MALZYNER [SHOFU INC.]
DURAGREEN1978-06-05
MAURO MALZYNER [SHOFU INC.]
COREMASTER1978-06-05
MAURO MALZYNER [SHOFU INC.]
CORAL STONES1978-06-05
MAURO MALZYNER [SHOFU INC.]
COMPOMASTER1978-06-05
MAURO MALZYNER [SHOFU INC.]
CHIPLESS WHEEL1978-06-05
MAURO MALZYNER [SHOFU INC.]
CERAMISTE1978-06-05
MAURO MALZYNER [SHOFU INC.]
CERAMASTER1978-06-05
MAURO MALZYNER [SHOFU INC.]
BROWNIE1978-06-05
MAURO MALZYNER [SHOFU INC.]
TPE1978-06-05
MAURO MALZYNER [SHOFU INC.]
SUMMA DISK1978-06-05
MAURO MALZYNER [SHOFU INC.]
ROBOT DIAMOND1978-06-05
MAURO MALZYNER [SHOFU INC.]
HYBRID1978-06-05
MAURO MALZYNER [SHOFU INC.]
GINGICURETTAGE1978-06-05
MAURO MALZYNER [SHOFU INC.]
BUR BUTLER1978-06-05

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