FDA Registration
Active
🇺🇸 United States
EK Lab Analog
Reg #: 3007135442
·
FEI: 3007135442
·
Expires 2025
Products
1
Proprietary Names
32
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- HIOSSEN INC.
- Registration Number
- 3007135442
- FEI Number
- 3007135442
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 85 BEN FAIRLESS DR
- City
- Fairless Hills
- State
- PA
- ZIP
- 19030
- Country
- US
Owner / Operator
- Firm Name
- Hiossen Inc.
- Operator Number
- 10026425
- Address
- 85 Ben Fairless Dr.
- City
- Fairless Hills
- State
- PA
- Postal Code
- 19030
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-05-02 |
Proprietary Names
EK Lab Analog
EK Transfer Impression Coping
Bite Impression Coping Driver
3D LAB ANALOG
ONE GUIDE SURGICAL TEMPLATE
Esthetic Low Transfer Impression Coping
Hiossen Ti Abutment Screw
Hiossen EbonyGold Abutment Screw
ET Fixture Lab Analog
Esthetic Low Lab Analog
ET Bite Index
Esthetic Low Polishing Protector
ET Fixture Pick-up Impression Coping
ET Pick-up Guide Pin
Fixture Lab Analog
ET Multi Digital Lab Analog
ET Scan Post - Cerec
Esthetic Low Pick-up Impression Coping Guide Pin
Laboratory Waxing Screw
ET Fixture Transfer Impression Coping
Esthetic Low Pick-up Impression Coping
ET Digital Lab Analog
ET Rigid Burn-out Cylinder
ET Digital Lab Analog Screw
Bushing
Plate
ET Scan Body
EK Pick Up Impression Coping
EK Scanbody
ET Bite Impression Coping
EK Bite Impression Coping
EK Digital Lab Analog
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device