FDA Registration
Active
🇰🇷 South Korea
Instruments (Parallel Pin, Tissue Punch)
Reg #: 3013271380
·
FEI: 3013271380
·
Expires 2025
Products
1
Proprietary Names
30
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEWON MEDIX, INC.
- Registration Number
- 3013271380
- FEI Number
- 3013271380
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #29, Sasang-ro, 375 beon-gil, Sasang-gu
- City
- Busan
- Country
- KR
Owner / Operator
- Firm Name
- Sewon Medix, Inc.
- Operator Number
- 10053110
- Address
- #29, Sasang-ro, 375 beon-gil, Sasang-gu
- City
- Busan
- State
- KR-26
- Postal Code
- 46946
- Country
- KR
- Correspondent
- Jinsoo Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2016-11-08 |
Proprietary Names
Instruments (Parallel Pin, Tissue Punch)
Lab Analog (IH Solid, IH2 Fixture, Multi-unit)
Driver (Fixture Driver, Screw Driver, Hand Driver, Solid Driver)
Surgical KIT
Wrench (Ratchet Wrench, Torque Wrench)
Plastic Impression Coping & Cylinder (IH Solid Impression Coping, IH Solid Burn-out Cylinder)
Impression Coping (IH Pick-up, IH Transfer, Multi-unit Transfer, Multi-unit Pick-up)
IH IMPRESSION COPING(AIHPIRN5011, AIHPIRN5015, IHPIRN5511, IHPIRN5515, AIHPIRN6011, AIHPIRN6015)
IH TRANSFER IMPRESSION COPING(AIHTIRH5511D, AIHTIRH5514D, AIHTIRH6011D, AIHTIRH6014D, AIHTIRH6511D, AIHTIRH6514D)
MULTI-UNIT PICK-UP IMPRESSION COPING(AMPIC480H, AMPIC480S, AMPIC450H, AMPIC450S, AMPIC550H, AMPIC550S)
IH IMPRESSION COPING(AIHPIRH6015, AIHPIRH6511, AIHPIRH6515)
IH IMPRESSION COPING(AIHPIRN6511, AIHPIRN6515)
IH SOLID BURN-OUT CYLINDER(IHSBC55S, IHSBC55B, IHSBC60S, IHSBC60B, IHSBC65S, IHSBC65B)
IH FIXTURE LAB ANALOG(IHFLAM120, IHFLAR120, IHFLAR120D, IHFLAM150, IHFLAR150, IHFLAR150D)
IH IMPRESSION COPING(AIHPIRH5011, AIHPIRH5015, AIHPIRH5511, AIHPIRH5515, AIHPIRH6011)
IH IMPRESSION COPING(AIHPIRH6011D, AIHPIRH6015D, AIHPIRH6511D, AIHPIRH6515D)
IH TRANSFER IMPRESSION COPING(AIHTIMH4011, AIHTIMH4014, AIHTIMH4511, AIHTIMH4514, AIHTIRH4511, AIHTIRH4514)
IH TRANSFER IMPRESSION COPING(AIHTIRH5011, AIHTIRH5014, AIHTIRH5511, AIHTIRH5514, AIHTIRH6011, AIHTIRH6014)
MULTI-UNIT TRANSFER IMPRESSION COPING(AMTIC450, AMTIC550)
IH SOLID IMPRESSION COPING(IHSIC40, IHSIC45, IHSIC50, IHSIC55, IHSIC60, IHSIC65)
IH SOLID BURN-OUT CYLINDER(IHSBC40S, IHSBC40B, IHSBC45S, IHSBC45B, IHSBC50S, IHSBC50B)
IH IMPRESSION COPING(AIHPIRH4511D, AIHPIRH4515D, AIHPIRH5011D, AIHPIRH5015D, AIHPIRH5511D, AIHPIRH5515D)
IH IMPRESSION COPING(AIHPIMN4011, AIHPIMN4015, IHPIMN4511, IHPIMN4515, AIHPIRN4511, AIHPIRN4515)
IH SOLID LAB ANALOG(IHSLA55S, IHSLA55M, IHSLA55L, IHSLA60S, IHSLA60M, IHSLA60L, IHSLA65S, IHSLA65M, IHSLA65L)
IH TRANSFER IMPRESSION COPING(AIHTIRH6511, AIHTIRH6514, AIHTIRH4511D, AIHTIRH4514D, AIHTIRH5011D, AIHTIRH5014D)
IH IMPRESSION COPING(AIHPIMH4011, AIHPIMH4015, IHPIMH4511, IHPIMH4515, AIHPIRH4511, AIHPIRH4515)
MULTI-UNIT LAB ANALOG(MLA480, MLA450, MLA550)
IH SOLID LAB ANALOG(IHSLA40S, IHSLA40M, IHSLA40L, IHSLA45S, IHSLA45M, IHSLA45L, IHSLA50S, IHSLA50M, IHSLA50L)
Fixture Mount (IHFMM35, IHFMR37, IHFMR40)
LT Abutment Carrier (LTPC180)
Establishment Types
Manufacture Medical Device