FDA Registration
Active
🇰🇷 South Korea
Evidence Implant Inc.
Reg #: 3006592743
·
FEI: 3006592743
·
Expires 2026
Products
6
Proprietary Names
3
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Evidence Implant Inc.
- Registration Number
- 3006592743
- FEI Number
- 3006592743
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 32, Innovalley-ro, Dong-gu, Daegu, 41065, Republic of Korea
- City
- Daegu
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K142426
Owner / Operator
- Firm Name
- Evidence Implant Inc.
- Operator Number
- 10024615
- Address
- 32, Innovalley-ro, Dong-gu
- City
- Daegu
- State
- KR-27
- Postal Code
- 41065
- Country
- KR
- Correspondent
- Yang Dongjun
US Agent
- Business Name
- EVIDENCE IMPLANT USA
- Contact Name
- Jun Heo
- Address
- 39-40 Broadway
- City
- Fair Lawn
- State
- NJ
- ZIP
- 07410
- Country
- US
- [email protected]
- Phone
- 201 6734088
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2015-11-19 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-08-23 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2011-08-23 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2011-08-23 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2011-08-23 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2020-12-20 |
Proprietary Names
OPUMC35 OPUMC40 OPUMB35 OPUMB40 OPURC OPURB OFMM OFMR41 OFMR41b OFMW55 OFMW55b OFMMS OFMRS
SD2207 SD2212 SD2214 SD2215 SD2807 SD2812 SD2814 SD2815 SD3507 SD3512 SD3514 SD3515 SD4215
Internal Hex Implant System
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)