Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006750855

FEI Number

3006750855

Entity Name

CHINA ZHONG YAN CHANG XING INTERNATIONAL CO. LTD

City/State/Country

Zibo City Shandong, CN

Establishment Address

No. 206 Industry YI Road, Huantai, Zibo City Shandong 256400, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

China Zhong Yan Chang ING International Co, LTD (Owner Number: 10087059)

Owner / Operator Contact Address

No. 206 Industry YI Road, Huantai, Zibo City, CN-SD 256400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ultrasonic Dental Tip Needle Dental Suction Device Tay, Fluoride

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-08-27
DZM	Needle, Dental	Dental	Class 1	872.4730	2023-01-06
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2023-01-09
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2023-01-06

Official Correspondent

Angela Batker

US Agent Details

Angela Batker Business: China Zhong Yan Chang ING International Co, LTD Email: abatker@lifespine.com Phone: (847) 8846117

Related Public Records

Same Entity

China Zhong Yan Chang ING International 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

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3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3003933619	MECTRON S.P.A.	CARASCO Genova, IT
9611253	NAKANISHI INC.	Kanuma Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006750855. Last updated year: 2026. Please use registration number 3006750855 when referencing this establishment in official correspondence.