FDA Registration
Active
🇰🇷 South Korea
SMD DENTAL LABORATORY
Reg #: 3038715999
·
FEI: 3038715999
·
Expires 2026
Products
14
Proprietary Names
18
Establishment Types
2
Classifications
14
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Registration Details
- Registration Name
- SMD DENTAL LABORATORY
- Registration Number
- 3038715999
- FEI Number
- 3038715999
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5, Jimdae-ro 72beon-gil
- City
- Heungdeok-gu Cheongju-si Chungbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K160828
Owner / Operator
- Firm Name
- SMD Dental Laboratory
- Operator Number
- 10094247
- Address
- 5, Jimdae-ro 72beon-gil
- City
- Heungdeok-gu Cheongju-si
- State
- Chungbuk
- Postal Code
- 28579
- Country
- KR
- Correspondent
- Man Young Bae
US Agent
- Business Name
- B2 Solutions, LLC
- Contact Name
- Van Bui
- Address
- 36 Shadow Brook Ln
- City
- Lander
- State
- WY
- ZIP
- 82520
- Country
- US
- [email protected]
- Phone
- 206 2148570
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Restoration, Porcelain | NSP | Class N | Unknown | No | 2025-12-31 |
| Dentures, Full | NSL | Class N | Unknown | No | 2025-12-31 |
| Restoration, Noble Metal | NSJ | Class N | Unknown | No | 2025-12-31 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-11-20 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2025-11-25 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2026-03-25 |
| Restoration, Base Metal | NSQ | Class N | Unknown | No | 2025-12-31 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2026-03-25 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-12-31 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2025-11-25 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2025-12-31 |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | Class 1 | Dental | No | 2026-01-22 |
| Restoration, Resin, Crown And Bridge | NSN | Class N | Unknown | No | 2025-12-31 |
| Restoration, Porcelain-Fused-To-Metal | NSO | Class N | Unknown | No | 2025-12-02 |
Proprietary Names
Emax Inlay/Onlay
Zirconia Crown
Emax Crown
Emax Veneer
Dentures, Full
Noble Crown
Custom Abutment
LUXEN Zr, LUXEN Smile
orthodontic retainer
Full Metal Crown
impression tray
Accessories, Implant, Dental, Endosseous
MAZIC Duro
Partial Denture
TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT
Restoration, Resin, Crown And Bridge
Custom Abutments
PFM
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)