Prexion Corp

FDA Filings

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

FDA Registration(s)
Registration Number3013433000
FEI Number3013433000
NameKeith Huang
Owner & OperatorPreXion Corporation
Contact Address1-14-1, Kandasuda-cho
Chiyoda-ku JP-13 Tokyo 101-0041 JP
Official Correspondent
  • Kenji Tanaka
  • 81-3-52977551-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2077 Gateway Place, Suite 120
San Jose, CA 95110 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3009191416
FEI Number3009191416
NameKeith Huang
Owner & OperatorPreXion Corporation
Contact Address1-14-1, Kandasuda-cho
Chiyoda-ku JP-13 Tokyo 101-0041 JP
Official Correspondent
  • Kenji Tanaka
  • 81-3-52977551-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2077 Gateway Place, Suite 120
San Jose, CA 95110 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3009259056
FEI Number3009259056
NamePREXION CORPORATION
Owner & OperatorPreXion Corporation
Contact Address1-14-1, Kandasuda-cho
Chiyoda-ku JP-13 Tokyo 101-0041 JP
Official Correspondent
  • Kenji Tanaka
  • 81-3-52977551-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1-14-1, Kandasuda-cho
Chiyoda-ku Tokyo, 101-0041 JP
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
PreXion Corporation
PreXion3D Explorer PRO2022-07-22
PREXION CORPORATION
PreXion3D Explorer PRO 2022-07-06
PreXion Corporation
PreXion3D Explorer EX2020-04-09
PREXION CORPORATION
PreXion3D Explorer2019-04-16
Keith Huang [PreXion Corporation]
PreXion3D Explorer2019-04-16
PreXion Corporation
PreXion3D Explorer2019-04-15
PREXION CORPORATION
PreXion3D Excelsior 2018-10-18
PreXion Corporation
PreXion 3D Excelsior2018-08-17
PreXion Corporation
PreXion3D Excelsior2018-01-19
PREXION CORPORATION
PreXion3D Excelsior2016-10-12
Keith Huang [PreXion Corporation]
PreXion3D Excelsior2016-10-12
PreXion Corporation
PreXion3D Excelsior2016-10-03

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092528774Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING15 PKG
2020091754992Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" "PREXION3D EXPLORER EX" P01-EX CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING37 PKG
2020091754992Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" "PREXION3D EXPLORER EX" P01-EX CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING37 PKG
2020090442956Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING "PREXION3D EXCELSIOR" CEPHALO UNIT9 PKG
2020081243725Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING "PREXION3D EXCELSIOR" CEPHALO UNIT "PREXION3D EXCELSIOR" STAND UNIT SB 2A19 PKG
2020071531726Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" "PREXION3D EXPLORER"" PX01-01A CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING "PREXION3D EXCELSIOR" STAND UNIT26 PKG
2020071531726Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" "PREXION3D EXPLORER"" PX01-01A CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING "PREXION3D EXCELSIOR" STAND UNIT26 PKG
2020070735910Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" "PREXION3D EXCELSIOR" CEPHALO UNIT CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING17 PKG
2020052027636Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" "PREXION3D EXCELSIOR" CEPHALO UNIT PARTS FOR "PREXION3D EXCELSIOR" CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING15 PKG
2020051322613Tokyo ,Japan -> Oakland, California"PREXION3D EXCELSIOR" CONE BEAM COMPUTED TOMOGRAPHY SYSTEM FOR DENTAL IMAGING20 PKG

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