Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010022489

FEI Number

3010022489

Entity Name

Modern Dental International Trading Limited

City/State/Country

Hong Kong, HK

Establishment Address

Room 1701-07, 09-16, 17/F., CEO Tower, 77 Wing Hong Street, Cheung Sha Wan, KLN, Hong Kong 999077, HK

Establishment Type(s)

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

Owner / Operator

MODERN DENTAL LABORATORY CO.LTD. (Owner Number: 9059261)

Owner / Operator Contact Address

UNITS 1708-1716,CEO TOWER,77 WING HONG STREET CHEUNG SHA WAN, KOWLOON, Hong Kong, CN-HK 999077, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150572

PMA Number

N/A

All Registered Proprietary Names

EMA Custom, EMA First Step TRIOCLEAR System TRIOCLEAR System IMMEDIATE DENTURE FULL DENTURE ACRYLIC DENTURE Surgical Guide Lab screw Orthodontic Appliance PARTIAL DENTURE REMOVABLE PARTIAL DENTURE FLEXIBLE DENTURE Ecodont retainer Finishing retainer Smartfix retainer Bleaching retainer Fixed Retainer Basic retainer Porcelain Fused to Metal Restoration Metal Restoration ( Base Metal) THE MOSES ELITE APPLIANCE Metal Restoration (Noble Metal) Emerald Herbst Respire Pink AT (Hard, Hard/Soft, EF)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2013-01-24
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2021-11-17
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-09-04
NSL	Dentures, Full	Unknown	Class N	N/A	2008-03-06
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-11-24
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2015-11-18
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2023-08-02
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2017-06-01
NSK	Dentures, Partial	Unknown	Class N	N/A	2008-03-06
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2010-05-28
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2012-09-10
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2015-11-18
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2012-09-10
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2021-11-17
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2012-09-10
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2023-10-19
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2023-10-19
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2021-11-17
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2017-06-01

Official Correspondent

Kevin Jin

US Agent Details

Ivan Siu Business: MicroDental California Email: isiu@microdental.com Phone: (925) 4356188

Related Public Records

Same Entity

MODERN DENTAL LABORATORY CO.LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015674959	Modern Dental Global Solutions Limited	Hong Kong, HK
3013950969	Modern Dental Laboratory (DG) Co., Ltd.	Dongguan Guangdong, CN
3019793783	Aceso Dental Laboratory Company Limited	An Phuoc Ward Dong Nai, VN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10
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 3010022489. Last updated year: 2026. Please use registration number 3010022489 when referencing this establishment in official correspondence.