Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043149181

FEI Number

3043149181

Entity Name

HANGZHOU WISE MEDICAL DEVICE CO.,LTD

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 508, #4 Building, No.672, Xintang Road, Shangcheng District, Hangzhou Zhejiang 310000, CN

Establishment Type(s)

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

Owner / Operator

Hangzhou Wise Medical Device Co.,Ltd (Owner Number: 10094837)

Owner / Operator Contact Address

Room 508, #4 Building, No.672, Xintang Road, Shangcheng District, Hangzhou, CN-ZJ 310000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Polishing Strip Micro screw drive handles, Orthodontic Tools, Self-ligation Tools Positioner Tooth Preformed Orthodontic Bracket, Lingual Button Orthodontic Plier File, Pulp canal Accessories, lmplant, Dental, Endosseous, Dental Implant Torque Wrench Dental crown Adhesive, Denture (All types) Orthodontic Tube Facebow Orthodotnic Elastics, Orthodontic Hooks, Aligner Chewies, Retainer Retrievers, Invisible Braces Box (ALIGNER BOX) Patient personal hygiene kit Orthodontic Wire Matrices Refill Sectional contoured metal Bur, Dental Dental Operating Light (lamp) Retainer, Screw Expansion Orthodontic Wax, Dental Orthodontic Band

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-12-28
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2025-12-28
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2025-12-28
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2025-12-28
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2025-12-28
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2025-12-28
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2025-12-28
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2025-12-28
KOM	Adhesive, Denture, Acacia And Karaya With Sodium Borate	Dental	Class 1	872.3400	2025-12-28
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2025-12-28
KCR	Facebow	Dental	Class 1	872.3220	2025-12-28
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2025-12-28
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2025-12-28
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2025-12-28
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2025-12-28
EJL	Bur, Dental	Dental	Class 1	872.3240	2025-12-28
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2025-12-28
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2025-12-28
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2025-12-28
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2025-12-28

Official Correspondent

SHOUYING LYU

US Agent Details

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

Related Public Records

Same Entity

Hangzhou Wise Medical Device 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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
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 3043149181. Last updated year: 2026. Please use registration number 3043149181 when referencing this establishment in official correspondence.