Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008493350

FEI Number

3008493350

Entity Name

AMEDCON MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Unit 201, Block 4, Meitai Industrial Park, 1231 Guanguang Road,, Guihua Community, Guanlan, Longhua District,, Shenzhen Guangdong 518110, CN

Establishment Type(s)

Remanufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Amedcon Medical Technology (Shenzhen) Co., Ltd. (Owner Number: 10043791)

Owner / Operator Contact Address

Unit 201, Block 4, Meitai Industrial Park, 1231 Guanguang Road,, Guihua Community, Guanlan, Longhua District,, Shenzhen, CN-GD 518110, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EZ STENT; EZ Stopper; Thermoplastic Drill Template Set EZ STENT; Thermoplastic Drill Template Set Empty Plastic Syringes for dental materials filling Plastic Capillary tips Plastic Syringe Caps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2015-08-27
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2013-03-21
EKB	Explorer, Operative	Dental	Class 1	872.4565	2013-03-21
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2013-03-21
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2013-03-21
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2021-06-01

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Tai Email: alanctai@cox.net Phone: (602) 4560568

Related Public Records

Same Entity

Amedcon Medical Technology (Shenzhen) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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 3008493350. Last updated year: 2026. Please use registration number 3008493350 when referencing this establishment in official correspondence.