Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023272670

FEI Number

3023272670

Entity Name

HANGZHOU THALES MEDTECH CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

2-3rd Floors, Building 2, Shanjing Technology Center, No. 167 Yunzhan Road, Zhuantang Street, Xihu District, Hangzhou Zhejiang 310000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hangzhou Thales Medtech Co., Ltd. (Owner Number: 10085109)

Owner / Operator Contact Address

2-3rd Floors, Building 2, Shanjing Technology Center, No. 167 Yunzhan Road, Zhuantang Street, Xihu District, Hangzhou, CN-ZJ 310000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Additive Manufacturing Zirconia Customized Restoration Zirconia Restoration

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-11-24
ELL	Teeth, Porcelain	Dental	Class 2	872.3920	2024-11-24
ELJ	Teeth, Artificial, Posterior With Metal Insert	Dental	Class 1	872.3900	2022-05-06

Official Correspondent

Chunxia Zhang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Hangzhou Thales Medtech 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
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023272670. Last updated year: 2026. Please use registration number 3023272670 when referencing this establishment in official correspondence.