Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027481489

FEI Number

3027481489

Entity Name

ZHONGSHAN MIIYEN NEW MATERIAL TECHNOLOGY CO., LTD

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

Unit 8, 2nd Floor, E Building, 104 Qihao Road, Torch Development Disctict, Zhongshan Guangdong 528437, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ZHONGSHAN MIIYEN NEW MATERIAL TECHNOLOGY CO., LTD (Owner Number: 10094371)

Owner / Operator Contact Address

Unit 8, 2nd Floor, E Building, 104 Qihao Road, Torch Development Disctict, Zhongshan, CN-GD 528437, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Powder, Porcelain Press Ceramic Dental Lithium Disilicate Glass-Ceramic PANDA Free PANDA P3 Plus PANDA Smart Y PANDA P2 Plus ELETRA SMART PANDA Smart P PIOS-EX5 PANDA P3 Intraoral Digital Impression Instrument PANDA P2 Dental Porcelain Formative Liquid Powder, Porcelain Dental Ceramic Dental Co-Cr porcelain alloy, model: KND/CW-CC Titanium alloy powder, model: KND/CW-TP Dental Co-Cr framework alloy, model: KND/CW-H Dental Ni-Cr porcelain alloy, model: KND/CW-NP Cobalt-Chromium alloy powder, model: KND/CW-LP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-11-25
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2025-11-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-11-25
EJH	Alloy, Metal, Base	Dental	Class 2	872.3710	2025-11-25

Official Correspondent

JIAXIN PENG

US Agent Details

Fanny Zhao Business: J & F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

ZHONGSHAN MIIYEN NEW MATERIAL 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
K810521	C.Vaupel Dental, Inc.	CO-SPAN 13.5 CASTING ALLOY	1981-03-17

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027481489. Last updated year: 2026. Please use registration number 3027481489 when referencing this establishment in official correspondence.