Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025436468

FEI Number

3025436468

Entity Name

Yilink (Tianjin) Biotechnology Co., Ltd.

City/State/Country

Tianjin, CN

Establishment Address

workshop 1-102, No. 5 Fengze Fourth Avenue, Balitai Town, Jinnan District, Tianjin 300350, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yilink (Tianjin) Biotechnology Co., Ltd. (Owner Number: 10086569)

Owner / Operator Contact Address

workshop 1-102, No. 5 Fengze Fourth Avenue, Balitai Town, Jinnan District, Tianjin, CN-TJ 300350, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242400

PMA Number

N/A

All Registered Proprietary Names

Dental Zirconia Ceramic Block Zirconia Block Glass Ceramics Dental Glass-Ceramic Block Dental porcelain powder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2022-11-20
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2023-02-16
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-12-11

Official Correspondent

Yaqiong ZHU

US Agent Details

Armando E Perez Business: DLS INTERNATIONAL LLC Email: Armando.Perez@aappco.co Phone: (951) 7220781

Related Public Records

Same Entity

Yilink (Tianjin) 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025436468. Last updated year: 2026. Please use registration number 3025436468 when referencing this establishment in official correspondence.