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Shenzhen Sunmc Dental Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance

Name: Shenzhen Sunmc Dental Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Sunmc Dental Technology Co., Ltd. is registered with the FDA (registration 3016998377) in Shenzhen Guangdong, China. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2022. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3016998377
Address: Room 313,Building A1,Weicheng Intelligent Industrial Park,No. 533 Gushu First Road,Guxing Community, Xixiang Subdistrict,Baoan District, Shenzhen Guangdong, China, 518126
Owner or operator: Shenzhen Sunmc Dental Technology Co., Ltd. (10070576)
Roles: Manufacturer
First device listed: April 17, 2020
Registered through: 2026
Brand names listed: Acrylic Denture, Activity rubber support, Aligner Chewies,Orthodotnic Elastics, Aligner removal tool,Retainer removal tool, All porcelain teeth, Alloy, Metal, Base, Alloy, gold-based noble metal, Attachment, Precision, All Denture Plastic Model and more

Devices it lists

Device	Product code	Class	Role	Source
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Alloy, Gold-Based Noble Metal	EJT	2	Manufacturer	accessdata.fda.gov
Alloy, Metal, Base	EJH	2	Manufacturer	accessdata.fda.gov
Attachment, Precision, All	EGG	1	Manufacturer	accessdata.fda.gov
Crown, Preformed	ELZ	1	Manufacturer	accessdata.fda.gov
Denture, Plastic, Teeth	ELM	2	Manufacturer	accessdata.fda.gov
Dentures, Full	NSL	N	Manufacturer	accessdata.fda.gov
Dentures, Partial	NSK	N	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Pusher, Band, Orthodontic	ECS	1	Manufacturer	accessdata.fda.gov
Restoration, Resin, Crown And Bridge	NSN	N	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Setter, Band, Orthodontic	ECR	1	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	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
August 16, 2022	K213026	Clear Aligner	NXC	Substantially Equivalent	Shenzhen Meiming Dentistry Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 16, 2022. 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.