Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022519816

FEI Number

3022519816

Entity Name

SHENZHEN YONGCHANGHE TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

1001, Huaide international building, No. 73, Fuyong section, Guangshen Road, Fuyong community, Fuyong street, Bao'an District, Shenzhen Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Yongchanghe Technology Co., Ltd. (Owner Number: 10084631)

Owner / Operator Contact Address

1001, Huaide international building, No. 73, Fuyong section, Guangshen Road, Fuyong community, Fuyong street, Bao'an District, Shenzhen, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental casting resin Denture Base Resin, Temporary C&B resin Ortho IBT resin Tray resin, Ortho model resin, Pro model resin, Gingiva mask resin SG resin Permanent Crown Resin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2024-01-02
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2024-12-12
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2022-03-15
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2022-03-15
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2022-12-21
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2024-12-12

Official Correspondent

Yujie Deng

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shenzhen Yongchanghe Technology 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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

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 3022519816. Last updated year: 2026. Please use registration number 3022519816 when referencing this establishment in official correspondence.