Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042370495

FEI Number

3042370495

Entity Name

YUCERA HEALTHCARE TECH USA INC

City/State/Country

Ontario, CA, US

Establishment Address

3100 E Cedar ST, Unit 17, Ontario, CA 91761, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Yucera Healthcare Tech USA INC (Owner Number: 10094232)

Owner / Operator Contact Address

3100 E Cedar ST, Unit 17, Ontario, CA 91761, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K214003

PMA Number

N/A

All Registered Proprietary Names

Zirconia Dental Ceramics Dental Zirconia Pre-shaded Block

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-11-19
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-11-19

Official Correspondent

Fiya Liao

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Yucera Healthcare Tech USA INC

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 3042370495. Last updated year: 2026. Please use registration number 3042370495 when referencing this establishment in official correspondence.