Data / Medical devices / China / Ningbo Sezen Technology Co., Ltd.
Ningbo Sezen Technology Co., Ltd.: FDA-registered device maker in Ningbo Zhejiang, China, 1 510(k) clearance
Ningbo Sezen Technology Co., Ltd. is registered with the FDA (registration 3021024355) in Ningbo Zhejiang, China. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021024355
- Address
- 2F, 13th Building, 518 Xinmei Road, Yinzhou District, Ningbo Zhejiang, China, 315000
- Owner or operator
- Ningbo Sezen Technology Co., Ltd. (10087624)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 21, 2023
- Registered through
- 2026
- Brand names listed
- FPD Reisn, LuxCreo Clear Aligner System, LuxCreo Clear Retainer System, LuxCreo Dental Clear Aligner Resin, LuxCreo Dental Night Guard Resin, LuxCreo Dental Surgical Guide Resin, PLATE, BASE, SHELLAC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Contract manufacturer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Contract manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Contract manufacturer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Contract manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 25, 2025 | K253365 | LuxCreo Flexible Partial Denture Resin | EBI | Substantially Equivalent | LuxCreo, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Positioner, Tooth, Preformed
- All makers of Mouthguard, Prescription
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Aligner, Sequential
- All makers of Maintainer, Space Preformed, Orthodontic
Updated November 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.