Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027341558

FEI Number

3027341558

Entity Name

TOPZIR BIOTECH CO., LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 520, Creative Center, No.69, Guangpu West Road, Huangpu District, Guangzhou Guangdong 510663, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Topzir Biotech Co., Ltd (Owner Number: 10087795)

Owner / Operator Contact Address

Room 520, Creative Center, No.69, Guangpu West Road, Huangpu District, Guangzhou, CN-GD 510663, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230003

PMA Number

N/A

All Registered Proprietary Names

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank 4D Ultra Fit Multilayer, 3D Pro Ultra Multilayer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2023-04-10

Official Correspondent

Hui Liu

US Agent Details

James St WU Business: Humiss Inc. Email: cc401vip@126.com Phone: (720) 7595888

Related Public Records

Same Entity

Topzir Biotech 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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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 3027341558. Last updated year: 2026. Please use registration number 3027341558 when referencing this establishment in official correspondence.