Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017609565

FEI Number

3017609565

Entity Name

PLASDENT SHANGHAI CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

12A Heng'an Mansion, No. 3 Lane 333, Shimen Rd. 2, Shanghai 200041, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Plasdent Shanghai Co., Ltd. (Owner Number: 10077952)

Owner / Operator Contact Address

12A Heng'an Mansion, No. 3 Lane 333, Shimen Rd. 2, Shanghai, CN-SH 200041, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Picks, Soft Picks, Toothpicks, Plastic Wedges Needle, Dental Absorber, Saliva, Paper, Paper Bibs, Paper Tray Covers Denture Cleanser cotton rolls Tray, Surgical, Instrument, Plastic dividers. Calipers Unit, Syringe, Air and/or Water-syringe covers, tip covers Holder, Film, X-ray films Absorber, Saliva, Paper, Paper Bibs, Paper Tray Covers Chair, Dental, without operative unit Syringe, periodontic, endodontic, irrigating Evacuator, Evacuation Suction Tips, Oral Evacuation Tips Toothbrush, Manual Applicator Absorbent Tips, Non-Sterile, Cotton Tip Applicators Retainer, Surgical Mirror, Mouth Material, Impression Tray, resin Retractors, Cheek Retractors Syringe, Restorative and Impression Material Gauze/Sponge, non-resorbable for external use Chair, Examination And Treatment, Dental Stools

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JET	Pick, Massaging	Dental	Class 1	872.6650	2020-10-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2020-12-14
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2020-12-14
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2023-04-27
EFN	Cotton, Roll	Dental	Class 1	872.6050	2020-12-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-12-14
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2020-12-14
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2020-12-14
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2020-12-14
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2020-12-14
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2020-12-14
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2020-12-14
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2020-12-14
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-12-14
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-12-14
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2020-12-14
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2020-12-14
EIG	Retractor, All Types	Dental	Class 1	872.4565	2020-12-14
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2020-12-14
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-12-14
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2020-12-14

Official Correspondent

Summer Qin

US Agent Details

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

Related Public Records

Same Entity

Plasdent Shanghai 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
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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

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3011089435	Allmed Industrial Limited	Shenzhen City Guangdong, CN
9710299	ACUMEN HOUSEWARE INDUSTRY (NANNING) CO., LTD.	NANNING Guangxi, CN
3005816808	Shummi Enterprise Co., Ltd.	Taipei, TW
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017609565. Last updated year: 2026. Please use registration number 3017609565 when referencing this establishment in official correspondence.