Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000892153

FEI Number

3000892153

Entity Name

SHENGIHO ENTERPRISE CO., LTD.

City/State/Country

TAICHUNG CITY, TW

Establishment Address

NO. 17, LANE 434, FU CHEN ROAD, WU FENG DISTRICT, TAICHUNG CITY --413-57, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHENGIHO ENTERPRISE CO., LTD. (Owner Number: 9033828)

Owner / Operator Contact Address

NO. 17, Lane 434, Fu Chen Road, WU FENG DISTRICT, TAICHUNG, TW-TXG --41357, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EVACUATOR, ORAL CAVITY-EVACUATOR TIPS, PLASTIC ADAPTORS FILM HOLDERS, ALIGNING SYSTEM, SNAP FILM HOLDER, SENSOR HOLDER Valve, Snap on tips, Lever, Tip Accessories Impression, Preformed, Transform Trays Retractors, Cheek Retractors PLASTIC TUBES PLASTIC TUBES, ASPIRATING TIPS, SALIVA EJECTORS SALIVA EJECTOR IMPRESSION TRAYS, MATERIAL, RESINS, BITE TRAYS PROTECTOR, DENTAL - Mouth Props, Mouth Night Guard, Bleaching Trays ACCESSORIES,Barrier Products,Plastic Pans,shield,ring,traps, DENTAL OPERATIVE U Dental Accessories, Oral cup, Water Bottle, DisposableTraps, Mixing Wells, Dappen Dishes, Brush handle, tips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2011-04-26
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2013-03-22
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2013-03-22
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2024-11-08
EIG	Retractor, All Types	Dental	Class 1	872.4565	2023-06-15
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2002-09-20
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2011-04-26
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2013-05-21
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2006-02-23

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

SHENGIHO ENTERPRISE 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000892153. Last updated year: 2026. Please use registration number 3000892153 when referencing this establishment in official correspondence.