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Tianjin Water Source Tech Co., Ltd.: FDA-registered device maker in Tianjin, China, 1 510(k) clearance

Name: Tianjin Water Source Tech Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tianjin Water Source Tech Co., Ltd. is registered with the FDA (registration 3025414363) in Tianjin, China. It lists 27 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 23, 2020. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3025414363
Address: 12-1-2302, Ziyue Mingxuan, No. 2 Bridge Street, Hedong District, Tianjin, China, 300000
Owner or operator: TIANJIN WATER SOURCE TECH CO., LTD (10086440)
Roles: Manufacturer
First device listed: November 9, 2022
Registered through: 2027
Brand names listed: Absorber, Saliva, Paper, Paper Bibs, Paper Tray Covers, Applicator Absorbent Tips, Non-Sterile, Cotton Tip Applicators, Chair, Examination And Treatment, Dental Stools, Cotton Rolls, cotton roll dispenser, Dental Barriers & Sleeves, Denture Cleanser, Evacuator, Evacuation Suction Tips, Oral Evacuation Tips, Floss, Dental and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Chair, Examination And Treatment	FRK	1	Manufacturer	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Manufacturer	accessdata.fda.gov
Cotton, Roll	EFN	1	Manufacturer	accessdata.fda.gov
Dental Barriers And Sleeves	PEM	2	Manufacturer	accessdata.fda.gov
Evacuator, Oral Cavity	EHZ	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
Holder, Film, X-Ray	EGZ	1	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	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	Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Pick, Massaging	JET	1	Manufacturer	accessdata.fda.gov
Retainer, Surgical	GCZ	1	Manufacturer	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer	accessdata.fda.gov
Syringe, Periodontic, Endodontic, Irrigating	EIC	1	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Manufacturer	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	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

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
December 23, 2020	K201604	Plasdent Disposable Barrier Sleeves and Barrier Film	PEM	Substantially Equivalent	Plasdent Corporation	accessdata.fda.gov

Compare with other makers

Updated December 23, 2020. 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.