Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013950969

FEI Number

3013950969

Entity Name

Modern Dental Laboratory (DG) Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Modern Dental Industrial Park, No. 7 and No.9, Nantou Road, Songshan Lake Hi-Tech Industrial Zone, Songshan lake Hi-Tech Industrial Zone, Dongguan Guangdong 523000, CN

Establishment Type(s)

Manufacture Medical 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

TEMPORARY CROWN AND BRIDGE COMPOSITE RESIN CROWN AND BRIDGE TRIOCLEAR System Emerald Herbst EMA Custom, EMA First Step DESS Dental Smart Solutions DESS Dental Smart Solutions Full Ceramic Restoration Porcelain Restoration Zirconia Crown / Bridge EMAX Crown / Bridge Lava restoration FMZ restoration ZirNEER Veneer Zir X restoration Calypso restoration TRIOCLEAR System IMMEDIATE DENTURE FULL DENTURE ACRYLIC DENTURE Respire Pink AT (Hard, Hard/Soft, EF) DESS Dental Smart Solutions Porcelain Fused to Metal Restoration DESS Dental Smart Solutions DESS Dental Smart Solutions DESS Dental Smart Solutions Surgical Guide Lab screw PARTIAL DENTURE REMOVABLE PARTIAL DENTURE FLEXIBLE DENTURE splint Screw Appliance ZenSplint Orthodontic Appliance

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2008-03-06
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-09-04
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	2015-11-18
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2013-01-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-02
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2008-05-27
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2021-11-17
NSL	Dentures, Full	Unknown	Class N	N/A	2008-03-06
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2021-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-02
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2012-09-10
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2017-06-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-02
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2017-06-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-02
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2017-11-24
NSK	Dentures, Partial	Unknown	Class N	N/A	2008-03-06
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2012-09-10

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
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
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.

Similar Registrations

Registration Number	Establishment Name	Location
3025358043	SHENZHEN ROBUST DENTAL LABORATORY CO., LIMITED	Shenzhen Guangdong, CN
3019793783	Aceso Dental Laboratory Company Limited	An Phuoc Ward Dong Nai, VN
3005126636	CORNERSTONE BIOCOMP ENTERPRISES INC	Bristol, PA, US
3008155930	DAMORE DENTAL LAB LLC	Houtzdale, PA, US
3012205930	ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO.,LTD	Zhuhai Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013950969. Last updated year: 2026. Please use registration number 3013950969 when referencing this establishment in official correspondence.