Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011539071

FEI Number

3011539071

Entity Name

HANGZHOU ANGSHENG ORTHODONTIC PRODUCTS CO., LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 404-2, Building 2, Xingcheng Development Building, Gongshu District, Hangzhou Zhejiang 310014, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Angsheng Orthodontic Products Co. Ltd (Owner Number: 10048742)

Owner / Operator Contact Address

Room 404-2, Building 2, Xingcheng Development Building, Gongshu District, Hangzhou, CN-ZJ 310014, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bracket, Metal Orthodontic ANGSHENG Band Performed Orthodontic Band, Material, Orthodontic Clamp, Wire, Orthodontic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2015-02-20
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-01-18
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2015-02-20
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2015-02-20
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2015-02-20

Official Correspondent

Siyuan Chen

US Agent Details

James Shao Business: ORTHODONTICS WORLD INC Email: jshao2020@yahoo.com Phone: (317) 3319938

Related Public Records

Same Entity

Hangzhou Angsheng Orthodontic Products Co. Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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 3011539071. Last updated year: 2026. Please use registration number 3011539071 when referencing this establishment in official correspondence.