Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031191035

FEI Number

3031191035

Entity Name

SHANDONG HENGFENG KERUI MEDICAL EQUIPMENT CO., LTD

City/State/Country

Qingdao City Shandong, CN

Establishment Address

Room 102, 1st Floor, and Room 202, 2nd Floor, Building 19, Liandong U Valley Life and Health City, No. 80, Tianjingshan 2nd Road, Huanxiu Street, Jimo District, Qingdao City Shandong 266200, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shandong Hengfeng Kerui Medical Equipment Co., Ltd (Owner Number: 10090457)

Owner / Operator Contact Address

Room 102, 1st Floor, and Room 202, 2nd Floor, Building 19, Liandong U Valley Life and Health City, No. 80, Tianjingshan 2nd Road, Huanxiu Street, Jimo District, Qingdao City, CN-SD 266200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Powered Toothbrush Chewing Gum, Torque Wrench, Locator Core Tool Tongue Scraper Gutta Percha Points, Injectable Root Canal Sealer Hand Driver, Lab hex Driver, Multi-Unit Hex Driver, Locator-Core Tool Device Unit, Oral Irrigation Dental scaler Orthodontic wax Dental Root Canal Instruments (Hand Files; Rotary files; Compactors; Enlargers; Paste Carrier; Barbed Broach) Dental Burs (CARBIDE BURS, Dental Burs) EDTA Root Canal Lubrication Gel Hand Dental Pluggers Abutment Screw, Multi-Unit Screw, Implant Analog, Impression Coping, Scan Body, Healing Cap, Hand Driver, Lab hex Driver, Multi-Unit Hex Driver, Torque Wrench, Locator-Core Tool, Cover Cap Orthodontic Wires (WIRE, ORTHODONTIC; Profa Wires)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2024-03-31
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-09-29
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2024-03-31
EKM	Gutta-Percha	Dental	Class 1	872.3850	2024-03-31
EIS	Remover, Crown	Dental	Class 1	872.4565	2026-06-07
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-03-31
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2024-03-31
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2024-03-31
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2024-03-31
EJL	Bur, Dental	Dental	Class 1	872.3240	2024-03-31
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2024-09-29
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2024-03-31
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-06-07
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2024-03-31

Official Correspondent

Heng Chen

US Agent Details

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

Related Public Records

Same Entity

Shandong Hengfeng Kerui Medical Equipment 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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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 3031191035. Last updated year: 2026. Please use registration number 3031191035 when referencing this establishment in official correspondence.