Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008081327

FEI Number

3008081327

Entity Name

F-SIX DENTAL TECHNOLOGY CO.,LIMITED

City/State/Country

Central Hong Kong, HK

Establishment Address

ROOM B 16/F Eubank Plaza 9 Chiu Lung Street,, Central Hong Kong 999077, HK

Establishment Type(s)

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

Owner / Operator

F-SIX DENTAL TECHNOLOGY CO.,LIMITED (Owner Number: 10056242)

Owner / Operator Contact Address

ROOM B 16/F Eubank Plaza 9 Chiu Lung Street,, Central Hong Kong, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Perio Tray prosthesis orthodntic Restoration, noble metal Dentures, full Restoration, porcelain ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS Plaster Models,Including mixed material,products with gypsum as the main component,Plaster models Restoration, base metal Restoration,porcelain-fused-to-metal

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
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2022-08-08
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2017-11-20
NSL	Dentures, Full	Unknown	Class N	N/A	2017-11-20
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2017-11-20
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-11-20
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2025-12-09
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2017-11-20
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2017-11-20

Official Correspondent

Xibing Xu

US Agent Details

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

Related Public Records

Same Entity

F-SIX DENTAL TECHNOLOGY CO.,LIMITED

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

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2086043	PAC-DENT INC.	Brea, CA, US
1941138	YOUNG DENTAL MANUFACTURING CO 1, LLC.	EARTH CITY, MO, US
3015276580	JINYUAN MEDICAL EQUIPMENT(TIANJIN)CO.,LTD	Tianjin, CN
3010583458	ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008081327. Last updated year: 2026. Please use registration number 3008081327 when referencing this establishment in official correspondence.