Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021284321

FEI Number

3021284321

Entity Name

ZIRDENT NEW MATERIAL CO.,LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

1st & 2nd floor, Building 5, Changsha Medical device Industrial Area,No.88, Section 1,Tengfei Road, Wangcheng Economic and Technological Development Zone, Changsha Hunan 410200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zirdent New Material Co.,Ltd (Owner Number: 10083428)

Owner / Operator Contact Address

1st & 2nd floor, Building 5, Changsha Medical device Industrial Area, No.88, Section 1, Tengfei Road, Wangcheng Economic and Technological Development Zone, Changsha, CN-HN 410200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212259

PMA Number

N/A

All Registered Proprietary Names

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Zirconia Blocks Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2021-11-18

Official Correspondent

Jia Li

US Agent Details

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

Related Public Records

Same Entity

Zirdent New Material 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

Similar Registrations

Registration Number	Establishment Name	Location
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3034729999	LIAONING RACHCERA MATERIAL TECHNOLOGY CO.,LTD.	Shenyang Liaoning, CN
3031595584	ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD	Taizhou Zhejiang, CN
3030464310	DOCTUS GLOBAL	Goyang-si, Gyeonggi-do, KR
3009740550	KEROX KFT.	Soskut Pest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021284321. Last updated year: 2026. Please use registration number 3021284321 when referencing this establishment in official correspondence.