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:

• PETER LEE
• OSSTEM IMPLANT Co., Ltd. Chair Business
• OSSTEM IMPLANT CO., LTD.

FDA Registration(s)

• Registration Number: 3007135442
• FEI Number: 3007135442
• Name: HIOSSEN INC.
• Owner & Operator: Hiossen Inc.
• Contact Address: 85 Ben Fairless Dr. ; Fairless Hills PA 19030 US
• Official Correspondent:
  • SEUNG MIN BAE
  • x-267-7597031-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 85 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 Number: 3010185635
• FEI Number: 3010185635
• Name: HIOSSEN INC.
• Owner & Operator: Hiossen Inc.
• Contact Address: 85 Ben Fairless Dr. ; Fairless Hills PA 19030 US
• Official Correspondent:
  • SEUNG MIN BAE
  • x-267-7597031-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 50 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	Device	Date
GUDID 00810125999888 HIOSSEN, INC.	ET O-ring Lab Analog (Small)	2024-12-31
GUDID 00810125999871 HIOSSEN, INC.	ET O-ring Lab Analog (Regular)	2024-12-31
GUDID 00810125999864 HIOSSEN, INC.	ET O-ring Set (Small)	2024-12-31
GUDID 00810125999857 HIOSSEN, INC.	ET O-ring Set (Regular)	2024-12-31
GUDID 00810125999840 HIOSSEN, INC.	ET O-ring Retainer Set	2024-12-31
GUDID 00810125999833 HIOSSEN, INC.	ET O-Ring Retainer Cap Set (Small)	2024-12-31
GUDID 00810125999826 HIOSSEN, INC.	ET O-Ring Retainer Cap Set (Regular)	2024-12-31
GUDID 00810125999819 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999802 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999796 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999789 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999772 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999765 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999758 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999741 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999734 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999727 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999710 HIOSSEN, INC.	ET STUD ABUTMENT	2024-12-31
GUDID 00810125999703 HIOSSEN, INC.	ET Stud abutment	2024-12-31
GUDID 00810126040671 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040664 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040657 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040640 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040633 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040626 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040619 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040602 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040596 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040589 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040572 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040565 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040558 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040541 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040534 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040527 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040510 HIOSSEN, INC.	EK III SA Fixture No Mount	2024-09-26
GUDID 00810126040503 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040497 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040480 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040473 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040466 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040459 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040442 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040435 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040428 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040411 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040404 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040398 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040381 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040374 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040367 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040350 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040343 HIOSSEN, INC.	EK III SA Fixture Pre-Mounted	2024-09-26
GUDID 00810126040336 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040329 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040312 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040305 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040299 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040282 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040275 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040268 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040251 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040244 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040237 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040220 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040213 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040206 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040190 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040183 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040176 HIOSSEN, INC.	EK III NH Fixture No Mount	2024-09-26
GUDID 00810126040169 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040152 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040145 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040138 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040121 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040114 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040107 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040091 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040084 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040077 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040060 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040053 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040046 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040039 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040022 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040015 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810126040008 HIOSSEN, INC.	EK III NH Fixture Pre-Mounted	2024-09-26
GUDID 00810125991820 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991813 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991806 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991790 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991783 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991769 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991752 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991745 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991738 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991721 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991677 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991646 HIOSSEN, INC.	ET Transfer Abutment Set	2024-07-15
GUDID 00810125991523 HIOSSEN, INC.	ET RIGID LAB ANALOG	2024-07-15
PMN K203360 Hiossen, Inc.	EK Implants And Abutments System	2022-01-07
PMN K161689 | NHA HIOSSEN INC.	ET Ziocera Abutments	2020-01-21
PMN K161689 | NHA HIOSSEN INC.	ET Rigid Abutments	2020-01-21
PMN K161689 | NHA HIOSSEN INC.	ET Quick Temporary Abutments	2020-01-21
PMN K161689 | NHA HIOSSEN INC.	ET Multi Abutments	2020-01-21
PMN K161689 | NHA HIOSSEN INC.	ET Freeform ST Abutments	2020-01-21
PMN K140507 | NHA HIOSSEN INC.	ET NP-Cast Abutments	2020-01-21
PMN K140507 | NHA HIOSSEN INC.	ET Esthetic Low Gold Cylinder	2020-01-21
PMN K110308 | NHA HIOSSEN INC.	ET Ziocera Angled Abutments	2020-01-21
PMN K110308 | NHA HIOSSEN INC.	ET Gold Cast Abutments	2020-01-21
PMN K073247 | DZE HIOSSEN INC.	ET Esthetic Low Plastic Cylinder	2020-01-21
PMN K191751 | DZE HIOSSEN INC.	EM Provisional	2020-01-15
PMN K191751 Hiossen, Inc.	EM Provisional	2019-12-16
PMN K191201 | DZE HIOSSEN INC.	EM SA Implant System	2019-11-18
PMN K191201 Hiossen, Inc.	EM SA Implant System	2019-11-15
PMN K182091 | NHA HIOSSEN INC.	ET Transfer Abutments	2019-10-24
PMN K182091 | NHA HIOSSEN INC.	ET Temporary Abutments	2019-10-24
PMN K182091 | NHA HIOSSEN INC.	ET Stud Abutments	2019-10-24
PMN K182091 | NHA HIOSSEN INC.	ET Multi-NP Cast Cylinder	2019-10-24
PMN K182091 | NHA HIOSSEN INC.	ET Multi-Angled Abutments	2019-10-24
PMN K182091 | NHA HIOSSEN INC.	ET Esthetic Low Temporary Cylinder	2019-10-24
PMN K182091 | NHA HIOSSEN INC.	ET Convertible Angled Cylinder	2019-10-24
PMN K182091 | NHA HIOSSEN INC.	ET Combination Angled Cylinder	2019-10-24
PMN K182091 | NHA HIOSSEN INC.	ET Angled Abutments	2019-10-24
PMN K183242 | DZE HIOSSEN INC.	ET IV SA Dental Implants	2019-05-22
PMN K183242 Hiossen, Inc.	ET IV SA Dental Implants	2019-05-21
PMN K173905 | KMW HIOSSEN INC.	SM3	2019-05-09
PMN K173905 | EGS HIOSSEN INC.	SM3	2019-05-09
PMN K173905 | EBW HIOSSEN INC.	SM3	2019-05-09
PMN K180527 | EKX HIOSSEN INC.	IS3	2018-06-19
PMN K180527 Hiossen, Inc.	IS3	2018-05-16
PMN K170421 | NHA HIOSSEN INC.	ET Hybrid Abutment	2018-01-12
PMN K170421 Hiossen Inc.	ET Hybrid Abutment	2018-01-11
PMN K162390 HIOSSEN INC.	ET Hybrid Abutment	2017-01-30
PMN K153332 | NHA HIOSSEN INC.	ETIII SA Fixture System (D3.2)	2016-11-08
PMN K153332 | DZE HIOSSEN INC.	ETIII SA Fixture System (D3.2)	2016-11-08
PMN K153332 HIOSSEN INC.	ETIII SA Fixture System (O3.2mm)	2016-10-27
PMN K151542 | NPM HIOSSEN INC.	A-Graft	2016-08-30
PMN K151542 HIOSSEN INC.	A-Oss	2016-08-03
PMN K151626 | DZE HIOSSEN INC.	ET III Nano-HA Fixture System	2016-07-27
PMN K151626 HiOSSEN Inc.	ET III Bio-SA Fixture System	2016-07-21
PMN K140934 | NHA HIOSSEN INC.	HIOSSEN IMPLANT SYSTEM	2014-11-18
PMN K140934 | DZE HIOSSEN INC.	HIOSSEN IMPLANT SYSTEM	2014-11-18
PMN K140934 HIOSSEN INC.	HIOSSEN IMPLANT SYSTEM	2014-11-12
PMN K132067 HIOSSEN INC.	MULTI ANGLED ABUTMENT SYSTEM	2013-12-20
PMN K123627 | NHA HIOSSEN INC.	ET SMARTFit Abutment	2013-08-06
PMN K123471 | DZE HIOSSEN INC.	ETII SA FIXTURE SYSTEM	2013-08-06
PMN K123471 HIOSSEN INC.	ETII SA FIXTURE SYSTEM	2013-07-05
PMN K123627 HIOSSEN INC.	ET SMARTFIT ABUTMENT	2013-06-28
PMN K112532 | DZE HIOSSEN INC.	ET III Bio-SA Fixture System Old	2012-09-18
PMN K112532 HIOSSEN INC.	ET II BIO-SA FIXTURE SYSTEM	2012-08-06
NDP HIOSSEN INC.	ONE GUIDE SURGICAL TEMPLATE	2011-05-02
NDP HIOSSEN INC.	Laboratory Waxing Screw	2011-05-02
NDP HIOSSEN INC.	Hiossen Ti Abutment Screw	2011-05-02
NDP HIOSSEN INC.	Hiossen EbonyGold Abutment Screw	2011-05-02
NDP HIOSSEN INC.	Fixture Lab Analog	2011-05-02
NDP HIOSSEN INC.	Esthetic Low Transfer Impression Coping	2011-05-02
NDP HIOSSEN INC.	Esthetic Low Polishing Protector	2011-05-02
NDP HIOSSEN INC.	Esthetic Low Pick-up Impression Coping	2011-05-02
NDP HIOSSEN INC.	Esthetic Low Pick-up Impression Coping Guide Pin	2011-05-02
NDP HIOSSEN INC.	Esthetic Low Lab Analog	2011-05-02
NDP HIOSSEN INC.	ET Scan Post - Cerec	2011-05-02
NDP HIOSSEN INC.	ET Rigid Burn-out Cylinder	2011-05-02
NDP HIOSSEN INC.	ET Pick-up Guide Pin	2011-05-02
NDP HIOSSEN INC.	ET Fixture Transfer Impression Coping	2011-05-02
NDP HIOSSEN INC.	ET Fixture Pick-up Impression Coping	2011-05-02
NDP HIOSSEN INC.	ET Fixture Lab Analog	2011-05-02
NDP HIOSSEN INC.	ET Bite Index	2011-05-02
NDP HIOSSEN INC.	3D LAB ANALOG	2011-05-02
PMN K103537 | NHA HIOSSEN INC.	ETIII SA Ultra Wide System (+healing abutment)	2011-04-26
PMN K103537 | DZE HIOSSEN INC.	ETIII SA Ultra Wide System (+healing abutment)	2011-04-26
PMN K103537 HIOSSEN INC.	ET III SA ULTRA WIDE SYSTEM	2011-03-10
PMN K101096 | DZE HIOSSEN INC.	HT III SA Fixture System	2010-10-25
PMN K101096 HIOSSEN INC.	HT III SA FIXTURE SYSTEM	2010-10-08
PMN K093889 | DZE HIOSSEN INC.	HG III Ultra Wide Fixture System	2010-05-18
PMN K093889 HIOSSEN INC.	MODIFICATION TO: HG III ULTRA WIDE SYSTEM	2010-04-22
PMN K083067 | DZE HIOSSEN INC.	HM System (Denture and Narrowridge)	2009-12-29
PMN K072959 | DZE HIOSSEN INC.	HM System(Denture)	2009-12-15
PMN K090237 | DZE HIOSSEN INC.	HG II Fixture System	2009-12-09
PMN K093352 | DZE HIOSSEN INC.	HG III Fixture System	2009-12-07
PMN K093352 HIOSSEN INC.	HG III FIXTURE SYSTEM	2009-11-24
NYE HIOSSEN INC.	Dental surgical kits	2009-06-29
PMN K090237 HIOSSEN INC.	HG II FIXTURE SYSTEM	2009-04-17
PMN K082213 | DZE HIOSSEN INC.	HG III Fixture System	2009-04-08
PMN K073465 | DZE HIOSSEN INC.	HG II Ultrawide System	2009-04-01
PMN K080387 | DZE HIOSSEN INC.	HU II / HS II Fixture System	2008-07-14

Related Finance Registrations

NCAGE Code	6JQD3	HIOSSEN, INC.
CAGE Code	6JQD3	HIOSSEN, INC.
S.A.M. Registration	6JQD3 [796083090]	HIOSSEN, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092932656	Pusan,South Korea -> Long Beach, California	(DENTAL UNIT CHAIR)K3 DENTAL UNIT CHAIR & SP ARE PARTS OF K3 DENTAL UNIT CHAIR	20 CTN
2020092918050	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	K3 DENTAL UNIT CHAIR & SPARE PARTS	5 CTN
2020081729696	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	HEALTH MASKS 6307.90	67 PKG
2020071126989	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PLASTIC STOCK BOX	300 PKG
2020040820438	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	CUSTOMIZED PROMOTION PRODUCTSAND ETC	5 PKG
2020040658189	Pusan,South Korea -> Los Angeles, California	DENTAL UNIT CHAIR (K3 DENTAL UNIT CHAIR & SPA RE PART)	19 PKG
2020022614286	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	(DENTAL UNIT CHAIR) K3 DENTAL UNIT CHAIR & SP ARE PARTS	19 PKG
2020022613194	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	(DENTAL UNIT CHAIR) K3 DENTAL UNIT CHAIR & SP ARE PARTS	20 CTN