Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010173003

FEI Number

3010173003

Entity Name

Shining 3D Tech Co.,Ltd.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No.1398 Xiangbin Road, Wenyan Street, Xiaoshan District, Building 3, No.111 Yanshankong Road, Wenyan Street, Xiaoshan District,, Hangzhou Zhejiang 311258, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shining 3D Tech Co., Ltd. (Owner Number: 10045483)

Owner / Operator Contact Address

No. 1398 Xiangbin Road, Wenyan Street Xiaoshan District, Building 3, No.111 Yanshankong Road, Wenyan Street,Xiaoshan District, Hangzhou, CN-ZJ 311258, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scanbody:CS-A48-A, CS-A48-B, CS-A48-C, CS-A48-D, CS-A48-E, CS-A48-F, CS-A48-G, CS-A48-H CS-A48-I, CS-A48-J, CS-A48-K, CS-A48-L, CS-A48M2-A, CS-A43-A, CS-A43-B CS-A40-B, CS-A60M2-A CS-B48-H,CS-B48-I,CS-B48-J,CS-B48-K,CS-B48-L Scanbody:CS-B48-A,CS-B48-B,CS-B48-C,CS-B48-D,CS-B48-E,CS-B48-F,CS-B48-G Scanbody:HACS-A15-1, HACS-A15-2, HACS-A15-3, HACS-A15-4, HACS-A15-5, HACS-A20-1, HACS-A20-2, HACS-A20-3 CS-A40-A, CS-A38M2-A, CS-A35-A, CS-A35-B Torque Wrench SCS Screwdriver for Ratchet HACS-A20-4, HACS-A20-5, HACS-A25-1, HACS-A25-2, HACS-A25-3, HACS-A25-4, HACS-A25-5 Scanbody:HACS-IPG, HAFS-IFT SN3D-AI, Dental Copilot Aoralscan 2, Aoralscan 3, Intelliscan 3X, ez2scan, Detection Eye AutoScan-DS-EX Pro(C), A-IS Pro, OS-200, Capella M2 AutoScan-DS-EX Pro(H), A-IS Pro3, OS GOLDY, Capella M5 Aoralscan Cameo3, Aoralscan L, Aoralscan 3 Wireless,Aoralscan Elite,Aoralscan Elite Wireless, Aoralscan Lync,Aoralscan Elf System, Optical Impression Aoralscan Elf Pro ACCUFAB-F1 Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations with Ceramix-Nano Dcraft-1,Dcraft-2,Dcraft-3,Dcraft-4 AccuFab-CEL MetiSmile, MetiSmile-MR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2024-05-14
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2013-11-21
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions	Dental	Class 1	872.2060	2023-04-14

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shining 3D Tech 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 3010173003. Last updated year: 2026. Please use registration number 3010173003 when referencing this establishment in official correspondence.