Data / Medical devices / China / Modern Dental Laboratory (DG) Co., Ltd.

Modern Dental Laboratory (DG) Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 2 510(k) clearances

Name: Modern Dental Laboratory (DG) Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Modern Dental Laboratory (DG) Co., Ltd. is registered with the FDA (registration 3013950969) in Dongguan Guangdong, China. It lists 15 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013950969
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, China, 523000
Owner or operator: MODERN DENTAL LABORATORY CO.LTD. (9059261)
Roles: Contract manufacturer, Manufacturer
First device listed: March 6, 2008
Registered through: 2026
Brand names listed: ACRYLIC DENTURE, Anti-Snoring Device, Basic retainer, Bleaching retainer, COMPOSITE RESIN CROWN AND BRIDGE, Calypso restoration, DESS Dental Smart Solutions, EMA Custom, EMA First Step and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Contract manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Dentures, Full	NSL	N	Manufacturer	accessdata.fda.gov
Dentures, Partial	NSK	N	Manufacturer	accessdata.fda.gov
Device, Anti-Snoring	LRK	2	Contract manufacturer	accessdata.fda.gov
Device, Jaw Repositioning	LQZ	2	Contract manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Prosthesis, Orthodontic	NSR	N	Manufacturer	accessdata.fda.gov
Restoration, Base Metal	NSQ	N	Manufacturer	accessdata.fda.gov
Restoration, Noble Metal	NSJ	N	Manufacturer	accessdata.fda.gov
Restoration, Porcelain	NSP	N	Manufacturer	accessdata.fda.gov
Restoration, Porcelain-Fused-To-Metal	NSO	N	Manufacturer	accessdata.fda.gov
Restoration, Resin, Crown And Bridge	NSN	N	Manufacturer	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 1, 2023	K231884	TRIOCLEAR System	NXC	Substantially Equivalent	Modern Dental Laboratory (Dg) Co., Ltd.	accessdata.fda.gov
July 6, 2021	K193622	TRIOCLEAR System	NXC	Substantially Equivalent	Perfection Aligner System Hong Kong Limited	accessdata.fda.gov

Compare with other makers

Updated September 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.