Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036269993

FEI Number

3036269993

Entity Name

GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Nanning Guangxi, CN

Establishment Address

6F, Kechuan Blgd, 25-1, Keyuan Road, Nanning Guangxi 530012, CN

Establishment Type(s)

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

Owner / Operator

Guangxi Ehall Medical Technology Co.,Ltd (Owner Number: 10092754)

Owner / Operator Contact Address

6F, Kechuan Blgd, 25-1, Keyuan Road, Nanning, CN-GX 530012, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cheek Retractor, Silicone Cheek Retractor Painless Anaesthesia Device Mixing Tip, Mixing Bowl, Mixing Spatula, Mixing Gun, Mixing pad Ultrasonic Cleaner Prophy cup, Nylon Prophy Brush, Prophy Angle, Proply Motor X1 Dental Implant Torque Wrench Micro Applicator, Adhesive Tip Fog Free Mirror, Dental Loupe Orthodontic Braket, Orthodontic Buccal Tube, Orthodontic Elastic, Orthodontic Arch Wires, Dental Teeth Model, Orthodontic Kit Dental Box, Denture Box, Cotton Roll Dispenser Disposable Irrigation Needle, Irrigation Syringe System, Disposable Dental Syringe, Pre-Bent Needle Tip, Capillary Tip, 3 Way Air Syringe, Air Water Syringe, Saliva Ejector Composite Heater

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2025-02-14
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2025-02-14
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-02-14
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-02-14
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-02-14
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2025-02-14
KXR	Applicator, Resin	Dental	Class 1	872.3140	2025-02-14
FSP	Loupe, Diagnostic/Surgical	General, Plastic Surgery	Class 1	878.4800	2025-02-14
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2025-02-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-02-14
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2025-02-14
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2025-02-14

Official Correspondent

Sophie Su

US Agent Details

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

Related Public Records

Same Entity

Guangxi Ehall Medical 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036269993. Last updated year: 2026. Please use registration number 3036269993 when referencing this establishment in official correspondence.