Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031595584

FEI Number

3031595584

Entity Name

ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO.,LTD

City/State/Country

Taizhou Zhejiang, CN

Establishment Address

#203,Building 8,Lecheng Industrial Park, Xinqian, HuangYan District, Taizhou Zhejiang 318020, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhejiang Zahndent Biotechnology Co.,Ltd (Owner Number: 10091053)

Owner / Operator Contact Address

#203,Building 8,Lecheng Industrial Park, Xinqian, HuangYan District, Taizhou, CN-ZJ 318020, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240672

PMA Number

N/A

All Registered Proprietary Names

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	2024-06-23

Official Correspondent

Yaping Huang

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (702) 7595888

Related Public Records

Same Entity

Zhejiang Zahndent Biotechnology 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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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 3031595584. Last updated year: 2026. Please use registration number 3031595584 when referencing this establishment in official correspondence.