Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025414363

FEI Number

3025414363

Entity Name

TIANJIN WATER SOURCE TECH CO., LTD.

City/State/Country

Tianjin, CN

Establishment Address

12-1-2302, Ziyue Mingxuan, No. 2 Bridge Street, Hedong District, Tianjin 300000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TIANJIN WATER SOURCE TECH CO., LTD (Owner Number: 10086440)

Owner / Operator Contact Address

12-1-2302, Ziyue Mingxuan, No. 2 Bridge Street, Hedong District, CN-TJ 300000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Plastic covers, plastic bags, plastic sleeves Shield, eye, opthalmic (including sunlamp protective eyewear and post-mydriatic eyewear, face shields Mirror, Mouth Dental Barriers & Sleeves Evacuator, Evacuation Suction Tips, Oral Evacuation Tips Material, Impression Tray, resin Applicator Absorbent Tips, Non-Sterile, Cotton Tip Applicators Unit, Syringe, Air and/or Water-syringe covers, tip covers Floss, Dental Tray, Surgical, Instrument, Plastic dividers Holder, Film, X-ray films Unit, operative dental, accessories Retractors, Cheek Retractors Syringes, Irrigating, Endodontic syringes, Periodontic syringes, Luer Lock Syringe, Restorative and Impression Material Chair, Examination And Treatment, Dental Stools Non-surgical isolation gown Retainer, Surgical Absorber, Saliva, Paper, Paper Bibs, Paper Tray Covers Needle, Dental TRAY, IMPRESSION, PREFORMED Picks, Soft Picks, Toothpicks, Plastic Wedges

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2023-01-06
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2023-01-06
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2023-01-06
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2023-01-06
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2022-11-09
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2022-11-09
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2023-01-06
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2022-11-09
JES	Floss, Dental	Dental	Class 1	872.6390	2023-01-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-11-09
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2023-01-06
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2022-11-09
EIG	Retractor, All Types	Dental	Class 1	872.4565	2023-01-06
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2023-01-06
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2023-01-06
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2023-01-06
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2023-01-06
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-09
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2022-11-09
DZM	Needle, Dental	Dental	Class 1	872.4730	2023-01-06
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2026-03-02
JET	Pick, Massaging	Dental	Class 1	872.6650	2023-01-06

Official Correspondent

Zang Lei

US Agent Details

Plasdent Corporation Business: Plasdent Corporation Email: larrywei@plasdent.com Phone: (909) 6200289

Related Public Records

Same Entity

TIANJIN WATER SOURCE TECH 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Similar Registrations

Registration Number	Establishment Name	Location
3005082946	HALLIM POINT IMPLANT CO., LTD	SIHEUNG-SI Gyeonggi, KR
3039246551	SUMMIT DENTAL SYSTEMS LLC.	Fort Lauderdale, FL, US
3038285060	GREATCARE 4U SDN BHD	Selangor Darul Ehsan, MY
3017604	ASEPTICO, INC.	WOODINVILLE, WA, US
9611445	TAKARA BELMONT CORPORATION	OSAKA, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025414363. Last updated year: 2026. Please use registration number 3025414363 when referencing this establishment in official correspondence.