NINGBO SEZEN TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Ningbo Zhejiang, CN · Registration 3021024355

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021024355
FEI Number
3021024355
Entity Name
NINGBO SEZEN TECHNOLOGY CO., LTD.
City/State/Country
Ningbo Zhejiang, CN
Establishment Address
2F, 13th Building, 518 Xinmei Road, Yinzhou District,, Ningbo Zhejiang 315000, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Ningbo Sezen Technology Co., Ltd. (Owner Number: 10087624)
Owner / Operator Contact Address
2F, 13th Building, 518 Xinmei Road, Yinzhou District,, Ningbo, CN-ZJ 315000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2023-03-22
KMY Positioner, Tooth, Preformed Dental Class 1 872.5525 2024-01-22
MQC Mouthguard, Prescription Unknown Class U N/A 2024-01-22
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2023-03-22
NXC Aligner, Sequential Dental Class 2 872.5470 2025-04-11

Official Correspondent

Hanyu Xiang

US Agent Details

Mike Yang Business: LuxCreo Inc. Email: Mike.Yang@LuxCreo.com Phone: (650) 3360888

Related Public Records

Same Entity

Ningbo Sezen Technology Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021024355. Last updated year: 2026. Please use registration number 3021024355 when referencing this establishment in official correspondence.
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