Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042256012

FEI Number

3042256012

Entity Name

QUANZHOU AGURU E-COMMERCE CO., LTD

City/State/Country

Quanzhou Fujian, CN

Establishment Address

1155 Binhai Street, Fengze District, Room 1401, Building 5, Phase II of Haichen Zunyu, Quanzhou Fujian 362000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Quanzhou Aguru E-commerce Co., Ltd (Owner Number: 10094233)

Owner / Operator Contact Address

1155 Binhai Street, Fengze District, Room 1401, Building 5, Phase II of Haichen Zunyu, Quanzhou, CN-FJ 362000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K921893

PMA Number

N/A

All Registered Proprietary Names

Plaque Remover for Teeth - Tartar Remover for Teeth, Dental Calculus Remover Teeth Cleaning Kit Plaque/Tartar Remover for Teeth, Dental Calculus Remover Teeth Cleaning Kit with LED Light & 5 Adjustable Modes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-11-19
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2026-02-05

Official Correspondent

Tingting Huang

US Agent Details

Mike Ryan Business: Simply Shipped, LLC Email: simplyshipped.agent@gmail.com Phone: (414) 3264114

Related Public Records

Same Entity

Quanzhou Aguru E-commerce 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
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06

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3011300255	W&H DENTALWERK BUERMOOS GMBH - SITE 2	BUERMOOS Salzburg, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042256012. Last updated year: 2026. Please use registration number 3042256012 when referencing this establishment in official correspondence.