Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015674959

FEI Number

3015674959

Entity Name

Modern Dental Global Solutions Limited

City/State/Country

Hong Kong, HK

Establishment Address

Room 1701-07, 09-16 CEO Tower, 77 Wing Hong Street, Cheung Sha Wan, Kowloon, 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

N/A

PMA Number

N/A

All Registered Proprietary Names

Respire Pink AT (Hard, Hard/Soft, EF) splint Screw Appliance ZenSplint Orthodontic Appliance TRIOCLEAR System TEMPORARY CROWN AND BRIDGE COMPOSITE RESIN CROWN AND BRIDGE Metal Restoration ( Base Metal) THE MOSES ELITE APPLIANCE Surgical Guide Lab screw Moses Appliance Anti-Snoring Device PARTIAL DENTURE REMOVABLE PARTIAL DENTURE FLEXIBLE DENTURE Porcelain Fused to Metal Restoration TRIOCLEAR System Full Ceramic Restoration Porcelain Restoration Zirconia Crown / Bridge EMAX Crown / Bridge Lava restoration FMZ restoration ZirNEER Veneer Zir X restoration Calypso restoration Metal Restoration (Noble Metal) IMMEDIATE DENTURE FULL DENTURE ACRYLIC DENTURE Orthodontic Appliance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2015-11-18
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2021-11-17
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2015-11-18
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2012-09-10
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2021-11-17
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2008-03-06
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2017-06-01
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2012-09-10
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2021-11-17
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-11-24
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2010-06-01
NSK	Dentures, Partial	Unknown	Class N	N/A	2008-03-06
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2012-09-10
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-09-04
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2008-05-27
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2012-09-10
NSL	Dentures, Full	Unknown	Class N	N/A	2008-03-06
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2023-08-02

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
3013950969	Modern Dental Laboratory (DG) Co., Ltd.	Dongguan Guangdong, CN
3010022489	Modern Dental International Trading Limited	Hong Kong, HK
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 3015674959. Last updated year: 2026. Please use registration number 3015674959 when referencing this establishment in official correspondence.