Manufacturer registered with FDA
Ningbo Sezen Technology Co., Ltd.
Ningbo, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Ningbo Sezen Technology Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Ningbo Sezen Technology Co., Ltd. | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Ningbo Sezen Technology Co.,Ltd | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Ningbo Sezen Technology Co., Ltd. | 2 | 2024–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Ningbo Sezen Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | LuxCreo Clear Aligner System | 2023 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | LuxCreo Clear Retainer SystemLuxCreo Dental Clear Aligner Resin | 2023 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | FPD Reisn | 2025 |
| Shellac Base PlateEEA · Class 1 | — | Maker | PLATE, BASE, SHELLAC | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | LuxCreo Dental Night Guard Resin | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | LuxCreo Dental Surgical Guide Resin | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Ningbo Sezen Technology Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: LuxCreo Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 25 Nov 2025 | K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo Inc. | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NINGBO SEZEN TECHNOLOGY CO., LTD.FDA reg. 3021024355 | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087624). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.