FDA Registration
Active
🇰🇷 South Korea
ESR KIT
Reg #: 3031886796
·
FEI: 3031886796
·
Expires 2025
Products
1
Proprietary Names
67
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OSSTEM IMPLANT CO., LTD.
- Registration Number
- 3031886796
- FEI Number
- 3031886796
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3, Magokjungang 12-ro
- City
- Gangseo-gu Seoul
- Country
- KR
Owner / Operator
- Firm Name
- Osstem Implant Co., Ltd.
- Operator Number
- 10089729
- Address
- 3, Magokjungang 12-ro
- City
- Gangseo-gu
- State
- Seoul
- Postal Code
- 07789
- Country
- KR
- Correspondent
- Hae Sung Kim
US Agent
- Business Name
- HIOSSEN, Inc.
- Contact Name
- Mateusz Leszczak
- Address
- 85 Ben Fairless Drive
- City
- Fairless Hills
- State
- PA
- ZIP
- 19030
- Country
- US
- [email protected]
- Phone
- 201 2660657
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fixture Mount Kit | NYE | Class 1 | Dental | No | 2024-02-19 |
Proprietary Names
ESR KIT
ESR FULL KIT COMPONENT
Lateral Approach Sinus (LAS) KIT
OneCAS KIT
OneGuide KIT CASE UPPER PLATE
123 Straight Full KIT
Split Kit - Offset
Osteotome Kit
GBR Kit
OssBuilder Kit
OneArch KIT
NEW Prosthetic KIT
Taper KIT
Prosthetic Kit Case Upper
122 Taper KIT
Denture 4U Kit
Ultra KIT
Assist KIT
SURGICAL KIT FOR GS
Ortho KIT
OneGuide Accessory KIT
Taper Kit Case
123 KIT
EFR Full KIT
Simple Kit
Selection KIT
Parallel Guide Advanced KIT
Positioning Guide Kit
One Day KIT
Sinus Lift Kit
One485 KIT
Standard KIT lower
HM KIT (HIOSSEN MS KIT)
EM Kit
OneGuide Training KIT
SmartGuide KIT
Crestal Approach Sinus (CAS) Kit
ESR Full KIT
HANARO KIT (HSK)
IM-Cure Kit Set
Prosthetic Simple KIT (OPSK)
ESSET KIT
485 Kit
OnePositioning KIT
CUSTOM KIT
Lateral Approach Sinus (LAS) KIT PLUS
Sinus KIT
Bone Screw KIT
Osstem Basic Instrument Kit
Positioning Guide FULL Kit
Bone Spreader KIT
Prosthetic Kit Case Low
NEW HANARO KIT (HKA)
122 Taper Full Kit
Osteo Kit
OneGuide KIT
Split Kit - Straight
OneMS KIT
122 TAPER KIT CASE MIDDLE PLAT
Taper Ultra KIT
Dr.Cho's Instrument Kit
ADVANCED KIT (HAK)
ORP KIT
Prosthetic Kit Case Middle
EFR KIT
Smart builder Kit
Standard KIT Upper
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility