FDA Registration
Active
🇹🇼 Taiwan
SMILDEN BIOTECHNOLOGY CO., LTD.
Reg #: 3011500388
·
FEI: 3011500388
·
Expires 2026
Products
12
Proprietary Names
12
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- SMILDEN BIOTECHNOLOGY CO., LTD.
- Registration Number
- 3011500388
- FEI Number
- 3011500388
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7F, NO.186, Jian 1st Rd.,, Chung Ho District
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K133071
Owner / Operator
- Firm Name
- Smilden Biotechnology CO., Ltd.
- Operator Number
- 10091129
- Address
- 7F, NO.186, Jian 1st Rd.,, Chung Ho District
- City
- New Taipei City
- State
- TW-NWT
- Postal Code
- 23553
- Country
- TW
- Correspondent
- Luisa Sam
US Agent
- Business Name
- Smilden Inc
- Contact Name
- Luisa Sam
- Address
- 2209 E Chapman Ave
- City
- Fullerton
- State
- CA
- ZIP
- 92831
- Country
- US
- [email protected]
- Phone
- 323 7178612
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2024-12-16 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2026-03-05 |
| Restoration, Resin, Crown And Bridge | NSN | Class N | Unknown | No | 2024-07-09 |
| Dentures, Full | NSL | Class N | Unknown | No | 2024-07-09 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2024-07-09 |
| Material, Impression | ELW | Class 2 | Dental | No | 2024-12-16 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2024-07-09 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2024-12-16 |
| Alloy, Gold-Based Noble Metal | EJT | Class 2 | Dental | No | 2024-07-09 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2024-07-09 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2024-07-09 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2024-07-09 |
Proprietary Names
Aoralscan 2, Aoralscan 3
Bluem tooth brush
Restoration, Resin, Crown and Bridge
Dentures, Full
Alloy, Metal, Base
PERFIT
Denture, Plastic, Teeth
Retainer
Alloy, gold-based noble metal
Attachment, Precision, All
Crown, Performed
Dentures, Partial
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device