Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018411778

FEI Number

3018411778

Entity Name

CHANGSHA HONCHON TECHNOLOGY CO., LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

Room 2316,2317,2319,2320, Building 1, Area 2 Jingiao Market Cluster, No. 1555 Purui Road,Huangjinyuan Street, Xiangjiang New District, Changsha Hunan 410200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changsha Honchon Technology Co., LTD (Owner Number: 10085686)

Owner / Operator Contact Address

Room 2316,2317,2319,2320, Building 1, Area 2 Jingiao Market Cluster, No. 1555 Purui Road,Huangjinyuan Street, Xiangjiang New District, Changsha, CN-HN 410200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Intraoral Scanner,HCE-IS-130,HCE-IS-300,HCE-IS-500,HCE-IS-800

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2022-07-20
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2025-07-29

Official Correspondent

Ling Li

US Agent Details

Jason Zhou Email: ShamrockIE49@hotmail.com Phone: (626) 6325067

Related Public Records

Same Entity

Changsha Honchon 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
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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3034729999	LIAONING RACHCERA MATERIAL TECHNOLOGY CO.,LTD.	Shenyang Liaoning, CN
3021284321	ZIRDENT NEW MATERIAL CO.,LTD	Changsha Hunan, CN
3031595584	ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD	Taizhou Zhejiang, CN
3030464310	DOCTUS GLOBAL	Goyang-si, Gyeonggi-do, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018411778. Last updated year: 2026. Please use registration number 3018411778 when referencing this establishment in official correspondence.