Ningbo Sezen Technology Co., Ltd.
Registered establishment in Ningbo, Zhejiang, China. 7 device types.
Ningbo Sezen Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Aligner, Sequential, Plate, Base, Shellac and 5 other device types. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | NINGBO SEZEN TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021024355 |
| FEI number | 3021024355 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Ningbo |
|---|---|
| Province | Zhejiang |
| Address | 2F, 13th Building, 518 Xinmei Road, Yinzhou District, |
| Postal code | 315000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | LuxCreo Dental Surgical Guide Resin | 2023 | 70 |
| Aligner, Sequential | Class 2 | LuxCreo Clear Aligner System | 2023 | 14 |
| Maintainer, Space Preformed, Orthodontic | Class 1 | LuxCreo Dental Clear Aligner Resin, LuxCreo Clear Retainer System | 2023 | 18 |
| Mouthguard, Prescription | Class U | LuxCreo Dental Night Guard Resin | 2024 | 6 |
| Plate, Base, Shellac | Class 1 | Plate, Base, Shellac | 2023 | 5 |
| Positioner, Tooth, Preformed | Class 1 | LuxCreo Dental Night Guard Resin | 2024 | 19 |
| Resin, Denture, Relining, Repairing, Rebasing | Class 2 | FPD Reisn | 2025 | 14 |
Clearances
No clearance names Ningbo Sezen Technology Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253365 | 2025-11-25 | EBI | Traditional | Luxcreo Inc. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.