HONCHON is committed to regulatory compliance and transparent manufacturing practices for dental CAD/CAM materials and digital dentistry devices.
According to the official U.S. Food & Drug Administration (FDA) Establishment Registration & Device Listing database, Changsha Honchon Technology Co., Ltd. is currently registered as an active medical device manufacturer.
This registration supports the lawful manufacture and export of HONCHON dental materials and digital dental devices for the U.S. market.
FDA Establishment Registration is a mandatory requirement for manufacturers and exporters of medical devices intended for distribution in the United States.
HONCHON’s registration confirms that:
The manufacturing entity is officially recorded in the FDA database
The establishment registration is active and up to date
Registered device categories and product listings are maintained
A designated U.S. Agent is appointed for regulatory communication
Annual registration renewal obligations are fulfilled
It is important to clarify that FDA establishment registration does not represent FDA product approval.
Rather, it confirms the legal regulatory status of the manufacturer under U.S. medical device regulations.
Based on the FDA public database records:
Establishment Name: Changsha Honchon Technology Co., Ltd.
FDA Registration Number: 3018411778
FEI Number: 3018411778
Registration Status: Active
Current Registration Year: 2026
Country: China
The FDA registration record was last updated on January 12, 2026, and remains publicly verifiable through the FDA medical device database.
HONCHON’s FDA registration includes device listings covering the following product categories:
Dental Zirconia Blank
Dental Zirconia Pre-Shaded Blank
Classification: Powder / Porcelain – Dental Materials
These materials are intended for the CAD/CAM milling of dental restorations such as crowns and bridges.
Intraoral Scanners
Models: HCE-IS-130, HCE-IS-300, HCE-IS-500, HCE-IS-800
Classification Name: System, Optical Impression, Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations
Device Class: Class II
Regulation Number: 21 CFR 872.3661
Medical Specialty: Dental
These device listings reflect FDA-recognized product classifications under the establishment registration framework.
Manufacturer: Changsha Honchon Technology Co., Ltd.
Registered Address:
Changsha, Hunan, China
In compliance with FDA regulations, HONCHON maintains a designated U.S. Agent to support regulatory correspondence and import-related communication with the FDA.
HONCHON operates under a structured quality management system covering product design, manufacturing, inspection, and traceability.
FDA establishment registration, together with device listing maintenance, reflects HONCHON’s ongoing regulatory responsibility as a medical device manufacturer serving regulated markets.
FDA establishment registration records and device listing information are publicly available through the U.S. FDA database.
This transparency enables distributors, partners, and regulatory authorities to independently verify HONCHON’s registration status and listed product scope.
FDA establishment registration confirms the legal registration status of the manufacturing entity and listed device categories.
It does not constitute FDA product approval or clearance.
Detailed regulatory documentation can be provided upon request to authorized partners, importers, and regulatory authorities in accordance with applicable laws and regulations.
