Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010598169

FEI Number

3010598169

Entity Name

Wellmed Dental Medical Supply Co., Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

301 Zhongxing Science and Technology Building, No.64, Xin'an 2nd Road, Baoan District, Shenzhen Guangdong CN-44, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wellmed Dental Medical Supply Co., Ltd. (Owner Number: 10047916)

Owner / Operator Contact Address

301 Zhongxing Science and Technology Building, No.64, Xin'an 2nd Road, Baoan District, Shenzhen, CN-GD CN-44, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACCESSORY, SURGICAL APPAREL UNIT, OPERATIVE DENTAL, ACCESSORIES Disposable Mask POINT, PAPER, ENDODONTIC Dispenser, solid medication Gauze/sponge,nonresorbable for external use WAX, DENTAL, INTRAORAL GOWN, EXAMINATION COVER, SHOE, OPERATING-ROOM GUTTA-PERCHA Disposable Dental Needles Apron, leaded Disposable Medical Face Mask (DF3-001) CUP, PROPHYLAXIS EVACUATOR, ORAL CAVITY TRAY, SURGICAL ALIGNER, BRACKET, ORTHODONTIC INSTRUMENT, SURGICAL, DISPOSABLE MOUTHPIECE, SALIVA EJECTOR APPLICATOR, ABSORBENT TIPPED, NON-STERILE Applicator Resin INSTRUMENTS, DENTAL HAND

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2015-12-14
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2015-04-06
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2019-09-24
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2023-12-29
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2014-11-15
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2015-12-14
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2023-05-15
FME	Gown, Examination	General Hospital	Class 1	880.6265	2015-12-14
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2015-12-14
EKM	Gutta-Percha	Dental	Class 1	872.3850	2023-12-29
DZM	Needle, Dental	Dental	Class 1	872.4730	2019-09-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-04-28
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2015-12-14
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-11-17
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2014-11-15
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2014-11-15
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-11-15
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2023-05-15
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-11-15
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2014-11-15
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2014-11-15
KXR	Applicator, Resin	Dental	Class 1	872.3140	2021-10-29
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2014-11-15

Official Correspondent

RENXIAN TANG

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Wellmed Dental Medical Supply Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

Similar Registrations

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3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010598169. Last updated year: 2026. Please use registration number 3010598169 when referencing this establishment in official correspondence.