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Wellmed Dental Medical Supply Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances

Name: Wellmed Dental Medical Supply Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Wellmed Dental Medical Supply Co., Ltd is registered with the FDA (registration 3010598169) in Shenzhen Guangdong, China. It lists 37 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 25, 2025. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3010598169
Address: 301 Zhongxing Science and Technology Building No.64, Xin'an 2nd Road, Baoan District, Shenzhen Guangdong, China, CN-44
Owner or operator: Wellmed Dental Medical Supply Co., Ltd. (10047916)
Roles: Exporter to the US, Manufacturer
First device listed: November 15, 2014
Registered through: 2027
Brand names listed: ACCESSORY, SURGICAL APPAREL, ALIGNER, BRACKET, ORTHODONTIC, APPLICATOR, ABSORBENT TIPPED, NON-STERILE, Applicator Resin, Apron, leaded, BEDDING, DISPOSABLE, MEDICAL, CAP, SURGICAL, COVER, SHOE, OPERATING-ROOM and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Aligner, Bracket, Orthodontic	ECQ	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Applicator, Resin	KXR	1	Manufacturer	accessdata.fda.gov
Apron, Leaded	EAJ	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Manufacturer	accessdata.fda.gov
Dental Barriers And Sleeves	PEM	2	Manufacturer	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Manufacturer	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	1	Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Manufacturer	accessdata.fda.gov
Floss, Dental	JES	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Manufacturer	accessdata.fda.gov
Gutta-Percha	EKM	1	Manufacturer	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Mask, Scavenging	KHA	1	Exporter to the US	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Mirror, Mouth	EAX	1	Manufacturer	accessdata.fda.gov
Mouthpiece, Saliva Ejector	DYN	1	Manufacturer	accessdata.fda.gov
Needle, Dental	DZM	1	Exporter to the US	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Tray, Surgical	LRP	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov
Unit, Syringe, Air And/Or Water	ECB	1	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	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
April 25, 2025	K243721	Self Sealing Sterilization Pouches	FRG	Substantially Equivalent	Wellmed Dental Medical Supply Co., Ltd.	accessdata.fda.gov
October 18, 2024	K242435	Dental Barrier and Sleeves	PEM	Substantially Equivalent	Wellmed Dental Medical Supply Co., Ltd.	accessdata.fda.gov
November 4, 2022	K222697	Disposable Medical Face Mask (DF3-001)	FXX	Substantially Equivalent	Wellmed Dental Medical Supply Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 25, 2025. 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.