Hiossen Inc

FDA Filings

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

Hiossen Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3007135442
FEI Number3007135442
NameHIOSSEN INC.
Owner & OperatorHiossen Inc.
Contact Address85 Ben Fairless Dr.
Fairless Hills PA 19030 US
Official Correspondent
  • SEUNG MIN BAE
  • x-267-7597031-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address85 BEN FAIRLESS DR
Fairless Hills, PA 19030 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device



Registration Number3010185635
FEI Number3010185635
NameHIOSSEN INC.
Owner & OperatorHiossen Inc.
Contact Address85 Ben Fairless Dr.
Fairless Hills PA 19030 US
Official Correspondent
  • SEUNG MIN BAE
  • x-267-7597031-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address50 Maple Street
Norwood, NJ 07648 US
Establishment Type
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III SA Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture No Mount 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
HIOSSEN, INC.
EK III NH Fixture Pre-Mounted 2022-01-21
Hiossen, Inc.
EK Implants And Abutments System2022-01-07
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Regular Non-Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Regular Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Regular Non-Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Regular Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Mini Non-Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Mini Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Mini Non-Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Mini Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Regular Hex 2021-12-29
HIOSSEN, INC.
ET FIXTURE PICK-UP IMPRESSION COPING Mini Hex 2021-12-29
HIOSSEN, INC.
ET Multi Ti Base Screw 2021-09-27
HIOSSEN, INC.
ET Multi Ti Base 2021-09-27
HIOSSEN, INC.
ET Multi Ti Base 2021-09-27
HIOSSEN, INC.
ET Multi Ti Base 2021-09-27
HIOSSEN, INC.
ET Multi Ti Base 2021-09-27
HIOSSEN, INC.
ET Multi Ti Base 2021-09-27
HIOSSEN, INC.
ET Multi Ti Base 2021-09-27
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN, INC.
Bite Impression Coping (Mini) 2021-08-04
HIOSSEN INC.
ET Ziocera Abutments2020-01-21
HIOSSEN INC.
ET Rigid Abutments2020-01-21
HIOSSEN INC.
ET Quick Temporary Abutments2020-01-21
HIOSSEN INC.
ET Multi Abutments2020-01-21
HIOSSEN INC.
ET Freeform ST Abutments2020-01-21
HIOSSEN INC.
ET NP-Cast Abutments2020-01-21
HIOSSEN INC.
ET Esthetic Low Gold Cylinder2020-01-21
HIOSSEN INC.
ET Ziocera Angled Abutments2020-01-21
HIOSSEN INC.
ET Gold Cast Abutments2020-01-21
HIOSSEN INC.
ET Esthetic Low Plastic Cylinder2020-01-21
HIOSSEN INC.
EM Provisional2020-01-15
Hiossen, Inc.
EM Provisional2019-12-16
HIOSSEN INC.
EM SA Implant System2019-11-18
Hiossen, Inc.
EM SA Implant System2019-11-15
HIOSSEN INC.
ET Transfer Abutments2019-10-24
HIOSSEN INC.
ET Temporary Abutments2019-10-24
HIOSSEN INC.
ET Stud Abutments2019-10-24
HIOSSEN INC.
ET Multi-NP Cast Cylinder2019-10-24
HIOSSEN INC.
ET Multi-Angled Abutments2019-10-24
HIOSSEN INC.
ET Esthetic Low Temporary Cylinder2019-10-24
HIOSSEN INC.
ET Convertible Angled Cylinder2019-10-24
HIOSSEN INC.
ET Combination Angled Cylinder2019-10-24
HIOSSEN INC.
ET Angled Abutments2019-10-24
HIOSSEN INC.
ET IV SA Dental Implants2019-05-22
Hiossen, Inc.
ET IV SA Dental Implants2019-05-21
HIOSSEN INC.
SM32019-05-09
HIOSSEN INC.
SM32019-05-09
HIOSSEN INC.
SM32019-05-09
HIOSSEN INC.
IS32018-06-19
Hiossen, Inc.
IS32018-05-16
HIOSSEN INC.
ET Hybrid Abutment2018-01-12
Hiossen Inc.
ET Hybrid Abutment2018-01-11
HIOSSEN INC.
ET Hybrid Abutment2017-01-30
HIOSSEN INC.
ETIII SA Fixture System (D3.2)2016-11-08
HIOSSEN INC.
ETIII SA Fixture System (D3.2)2016-11-08
HIOSSEN INC.
ETIII SA Fixture System (O3.2mm)2016-10-27
HIOSSEN INC.
A-Graft2016-08-30
HIOSSEN INC.
A-Oss2016-08-03
HIOSSEN INC.
ET III Nano-HA Fixture System2016-07-27
HiOSSEN Inc.
ET III Bio-SA Fixture System2016-07-21
HIOSSEN INC.
HIOSSEN IMPLANT SYSTEM2014-11-18
HIOSSEN INC.
HIOSSEN IMPLANT SYSTEM2014-11-18
HIOSSEN INC.
HIOSSEN IMPLANT SYSTEM2014-11-12
HIOSSEN INC.
MULTI ANGLED ABUTMENT SYSTEM2013-12-20
HIOSSEN INC.
ET SMARTFit Abutment2013-08-06
HIOSSEN INC.
ETII SA FIXTURE SYSTEM2013-08-06
HIOSSEN INC.
ETII SA FIXTURE SYSTEM2013-07-05
HIOSSEN INC.
ET SMARTFIT ABUTMENT2013-06-28
HIOSSEN INC.
ET III Bio-SA Fixture System Old2012-09-18
HIOSSEN INC.
ET II BIO-SA FIXTURE SYSTEM2012-08-06
HIOSSEN INC.
ONE GUIDE SURGICAL TEMPLATE2011-05-02
HIOSSEN INC.
Laboratory Waxing Screw2011-05-02
HIOSSEN INC.
Hiossen Ti Abutment Screw2011-05-02
HIOSSEN INC.
Hiossen EbonyGold Abutment Screw2011-05-02
HIOSSEN INC.
Fixture Lab Analog2011-05-02
HIOSSEN INC.
Esthetic Low Transfer Impression Coping2011-05-02
HIOSSEN INC.
Esthetic Low Polishing Protector2011-05-02
HIOSSEN INC.
Esthetic Low Pick-up Impression Coping2011-05-02
HIOSSEN INC.
Esthetic Low Pick-up Impression Coping Guide Pin2011-05-02
HIOSSEN INC.
Esthetic Low Lab Analog2011-05-02
HIOSSEN INC.
ET Scan Post - Cerec2011-05-02
HIOSSEN INC.
ET Rigid Burn-out Cylinder2011-05-02
HIOSSEN INC.
ET Pick-up Guide Pin2011-05-02
HIOSSEN INC.
ET Fixture Transfer Impression Coping2011-05-02
HIOSSEN INC.
ET Fixture Pick-up Impression Coping2011-05-02
HIOSSEN INC.
ET Fixture Lab Analog2011-05-02
HIOSSEN INC.
ET Bite Index2011-05-02
HIOSSEN INC.
3D LAB ANALOG2011-05-02
HIOSSEN INC.
ETIII SA Ultra Wide System (+healing abutment)2011-04-26
HIOSSEN INC.
ETIII SA Ultra Wide System (+healing abutment)2011-04-26
HIOSSEN INC.
ET III SA ULTRA WIDE SYSTEM2011-03-10
HIOSSEN INC.
HT III SA Fixture System2010-10-25
HIOSSEN INC.
HT III SA FIXTURE SYSTEM2010-10-08
HIOSSEN INC.
HG III Ultra Wide Fixture System2010-05-18
HIOSSEN INC.
MODIFICATION TO: HG III ULTRA WIDE SYSTEM2010-04-22
HIOSSEN INC.
HM System (Denture and Narrowridge)2009-12-29
HIOSSEN INC.
HM System(Denture)2009-12-15
HIOSSEN INC.
HG II Fixture System2009-12-09
HIOSSEN INC.
HG III Fixture System2009-12-07
HIOSSEN INC.
HG III FIXTURE SYSTEM2009-11-24
HIOSSEN INC.
Dental surgical kits2009-06-29
HIOSSEN INC.
HG II FIXTURE SYSTEM2009-04-17
HIOSSEN INC.
HG III Fixture System2009-04-08
HIOSSEN INC.
HG II Ultrawide System2009-04-01
HIOSSEN INC.
HU II / HS II Fixture System2008-07-14

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092932656Pusan,South Korea -> Long Beach, California(DENTAL UNIT CHAIR)K3 DENTAL UNIT CHAIR & SP ARE PARTS OF K3 DENTAL UNIT CHAIR20 CTN
2020092918050Pusan,South Korea -> New York/Newark Area, Newark, New JerseyK3 DENTAL UNIT CHAIR & SPARE PARTS5 CTN
2020081729696Pusan,South Korea -> New York/Newark Area, Newark, New JerseyHEALTH MASKS 6307.9067 PKG
2020071126989Pusan,South Korea -> New York/Newark Area, Newark, New JerseyPLASTIC STOCK BOX300 PKG
2020040820438Pusan,South Korea -> New York/Newark Area, Newark, New JerseyCUSTOMIZED PROMOTION PRODUCTSAND ETC5 PKG
2020040658189Pusan,South Korea -> Los Angeles, CaliforniaDENTAL UNIT CHAIR (K3 DENTAL UNIT CHAIR & SPA RE PART)19 PKG
2020022614286Pusan,South Korea -> New York/Newark Area, Newark, New Jersey(DENTAL UNIT CHAIR) K3 DENTAL UNIT CHAIR & SP ARE PARTS19 PKG
2020022613194Pusan,South Korea -> New York/Newark Area, Newark, New Jersey(DENTAL UNIT CHAIR) K3 DENTAL UNIT CHAIR & SP ARE PARTS20 CTN

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.