Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015531834

FEI Number

3015531834

Entity Name

FOO TIAN DENTAL LABORATORY

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

901A, B6 Bld, Junfeng Industrial Park, Yonghe Road, Heping, Fuhai, Bao'an, Shenzhen Guangdong 518103, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Foo Tian Dental Laboratory (Owner Number: 10060714)

Owner / Operator Contact Address

901A, B6 Bld, Junfeng Industrial Park, Yonghe Road, Heping, Fuhai, Bao'an, 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

Orthodontic Appliance and customized clear aligners Restoration, porcelain-fused-to-metal Veneers or facings Customized Dental Implant Suprastructure&Substructure

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2023-05-12
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2019-06-17
ELK	Teeth, Artificial, Backing And Facing	Dental	Class 1	872.3910	2023-05-12
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-05-12

Official Correspondent

Dino Yi

US Agent Details

Jimmy Chen Business: Hyun Turle E-Commerce Inc Email: Kin.grace@hotmail.com Phone: (323) 5104660

Related Public Records

Same Entity

Foo Tian Dental Laboratory

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.

Similar Registrations

Registration Number	Establishment Name	Location
3010462491	DW Lingual Systems GmbH	Bad Essen Lower Saxony, DE
3009257060	Ortho Traction Pads	Norwalk, CT, US
3027343382	UNIVY TECHNOLOGY ADVANCED CO. LTD	Shanghai, CN
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015531834. Last updated year: 2026. Please use registration number 3015531834 when referencing this establishment in official correspondence.