EDENTAL LAB CO., LTD

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3045005836

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3045005836
FEI Number
3045005836
Entity Name
EDENTAL LAB CO., LTD
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
8B, Building 1, Kangtaijian Health Industry Building, No.7 Rongtian Road, Jinsha Community, Kenzi Street, Pingshan District, Shenzhen Guangdong 518000, 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
Edental Lab Co., Ltd (Owner Number: 10095545)
Owner / Operator Contact Address
8B, Building 1, Kangtaijian Health Industry Building, No.7 Rongtian Road, Jinsha Community, Kenzi Street, Pingshan District, Shenzhen, CN-GD 518000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-03-27
NSP Restoration, Porcelain Unknown Class N N/A 2026-03-27
NSQ Restoration, Base Metal Unknown Class N N/A 2026-03-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-03-27
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2026-03-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-03-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-03-27
NSL Dentures, Full Unknown Class N N/A 2026-03-27
NSK Dentures, Partial Unknown Class N N/A 2026-03-27
NSM Restoration, Resin Unknown Class N N/A 2026-03-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-03-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-03-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-03-27
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2026-03-27
NSJ Restoration, Noble Metal Unknown Class N N/A 2026-03-27

Official Correspondent

Guosheng Mo

US Agent Details

Jessie Yao Business: MEDRIGHT TECH INC Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Edental Lab 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
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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 3045005836. Last updated year: 2026. Please use registration number 3045005836 when referencing this establishment in official correspondence.
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