Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008370577

FEI Number

3008370577

Entity Name

SHANGHAI SMEDENT MEDICAL INSTRUMENT CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

Suite 310, 10th Building,, No.3599 Qixin Rd,, Shanghai 201101, CN

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

Shanghai smedent medical instrument co., ltd. (Owner Number: 10051351)

Owner / Operator Contact Address

Suite 310, 10th Building,, No.3599 Qixin Rd,, Shanghai, CN-SH 201101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

starryshine Starryshine applicator, resin - dental applicators, mixing pad; mixing well; brush handle, brush tips; Product: DYN - Mouthpiece, saliva ejector, saliva ejector tips, evacuator tips, aspirator tips paper tray cover Starryshine Disposable Traps, Plastic Retainer Denture, Cuspidor Strainer Impression tray performed, paper tray cover prophy angle ,prophy brush, prophy cup, prophy point Wood & Cotton tip applicators, Plastic & Cotton applicators Isolation gowns ,lab gowns ,surgical gowns Isolation gowns ,Surgical gowns Starryshine Dental Diamond burs Dental Carbide burs air water syringe tips plastic w/Metal core, metal air water syringe tips metal Starryshine cotton roll Plastic Film Holder, Bite Block, Barrier Envelope, Sensor Holder, Film Mount Curved Utility Syringe, Syringe, pre-bent needle tips ,Endodontic Irrigation Syringe Welding Wire, Welding Rod, Metal Powder, Alloy Powder , Co-Cr discs ,Titanium Discs Starryshine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2016-12-19
KXR	Applicator, Resin	Dental	Class 1	872.3140	2024-08-04
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2024-08-02
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2024-08-07
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2016-12-19
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2025-07-28
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2024-08-04
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2024-08-04
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-08-04
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-12-16
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2016-12-19
EJL	Bur, Dental	Dental	Class 1	872.3240	2016-03-04
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2024-08-04
EKM	Gutta-Percha	Dental	Class 1	872.3850	2016-12-19
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-08-04
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2025-07-28
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2024-12-18
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2024-09-25
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2016-12-19

Official Correspondent

SHAN LIU

US Agent Details

Stone Liu Business: SDS Dental Supply Inc. Email: stone6363@gmail.com Phone: (626) 9919763

Related Public Records

Same Entity

Shanghai smedent medical instrument 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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17

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3003418325	Integra LifeSciences Corporation	Princeton, NJ, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008370577. Last updated year: 2026. Please use registration number 3008370577 when referencing this establishment in official correspondence.