FDA Registration
Active
🇨🇳 China
NINGBO SEZEN TECHNOLOGY CO., LTD.
Reg #: 3021024355
·
FEI: 3021024355
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- NINGBO SEZEN TECHNOLOGY CO., LTD.
- Registration Number
- 3021024355
- FEI Number
- 3021024355
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2F, 13th Building, 518 Xinmei Road, Yinzhou District,
- City
- Ningbo Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K253365
Owner / Operator
- Firm Name
- Ningbo Sezen Technology Co., Ltd.
- Operator Number
- 10087624
- Address
- 2F, 13th Building, 518 Xinmei Road, Yinzhou District,
- City
- Ningbo
- State
- Zhejiang
- Postal Code
- 315000
- Country
- CN
- Correspondent
- Hanyu Xiang
US Agent
- Business Name
- LuxCreo Inc.
- Contact Name
- Mike Yang
- Address
- 350 W. Ontario Street Suite 700 Chicago,lL.60654
- City
- Chicago
- State
- IL
- ZIP
- 60654
- Country
- US
- [email protected]
- Phone
- 650 3360888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2023-03-22 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2024-01-22 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2024-01-22 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2023-03-22 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2025-04-11 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2023-03-21 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2025-12-04 |
Proprietary Names
LuxCreo Dental Clear Aligner Resin
LuxCreo Clear Retainer System
LuxCreo Dental Night Guard Resin
LuxCreo Dental Surgical Guide Resin
LuxCreo Clear Aligner System
PLATE, BASE, SHELLAC
FPD Reisn
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device