Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017618678

FEI Number

3017618678

Entity Name

CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

NO.9 Changyang road, West Taihu Science Techology Industrial Park, Changzhou Jiangsu 213100, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ChangZhou BoMedent Medical Technology Co., Ltd (Owner Number: 10078266)

Owner / Operator Contact Address

NO.9 Changyang road, West Taihu Science Techology Industrial Park, Changzhou, CN-JS 213100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endodontic Obturation Devices SCM-019, iBon, iBon Mini, iBon Mini-SE Ultrasonic Endo Activation Device (Model: Actor I pro) Endodontic Obturation Devices

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2021-03-12
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2023-10-26
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2022-09-12
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2021-03-12

Official Correspondent

No official correspondent registered.

US Agent Details

Jessie Yao Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

ChangZhou BoMedent Medical Technology 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017618678. Last updated year: 2026. Please use registration number 3017618678 when referencing this establishment in official correspondence.