Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017903664

FEI Number

3017903664

Entity Name

FSEVEN DENTAL TECHNOLOGY ZHUHAI CO.,LTD

City/State/Country

ZHUHAI Guangdong, CN

Establishment Address

1ST BUILDING, NO.1, DINGWAN 7TH RD, SANZAO TOWN,, ZHUHAI Guangdong 519040, CN

Establishment Type(s)

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

Owner / Operator

FSEVEN DENTAL TECHNOLOGY ZHUHAI CO.,LTD (Owner Number: 10078931)

Owner / Operator Contact Address

1ST BUILDING, NO.1, DINGWAN 7TH RD, SANZAO TOWN,, ZHUHAI, CN-GD 519040, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Perio Tray Restoration, Porcelain-fused-to-metal ALLOR,GOLD-BASED NOBLE METAL Restoration, resin Restoration, base metal TEETH,PREFORMED GOLD DENTURE CLASP,WIRE Restoration, noble metal Restoration, porcelain CLASP,PREFORMED BRACKET,METAL,ORTHODONTIC prosthesis orthodntic Prosthesis, orthodontic ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Plaster Models,Including Mixed material,Products with Gypsum as the main component

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2022-09-08
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2020-11-11
EJT	Alloy, Gold-Based Noble Metal	Dental	Class 2	872.3060	2020-11-11
NSM	Restoration, Resin	Unknown	Class N	N/A	2020-11-11
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2020-11-11
ELN	Teeth, Preformed Gold Denture	Dental	Class 1	872.3580	2020-11-11
EJW	Clasp, Wire	Dental	Class 1	872.3285	2020-11-11
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2020-11-11
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2020-11-11
EHP	Clasp, Preformed	Dental	Class 1	872.3285	2020-11-11
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2020-11-11
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2021-08-23
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2020-11-11
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2025-12-22

Official Correspondent

KELLY YANG

US Agent Details

JIMMY chen Business: UGK-LVM UNITED INC Email: 1841621950@qq.com Phone: (323) 5104660

Related Public Records

Same Entity

FSEVEN DENTAL TECHNOLOGY ZHUHAI 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
K915626	Ivoclar North America, Inc.	EZ GOLD	1992-02-25
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017903664. Last updated year: 2026. Please use registration number 3017903664 when referencing this establishment in official correspondence.