Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012441963

FEI Number

3012441963

Entity Name

SHENZHEN UPCERA DENTAL TECHNOLOGY CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

2nd Floor, Tsinghua IT Port B, High-tech Park, Nanshan District, Shenzhen Guangdong 518057, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shenzhen Upcera Dental Technology Co., Ltd (Owner Number: 10052091)

Owner / Operator Contact Address

Floor 5,R&D Building B, Tsinghua IT Port,No.1 Xindong Road,Songping Shan Community,, Xili Sub-District, Nanshan District, Shenzhen, CN-GD 518057, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141723

PMA Number

N/A

All Registered Proprietary Names

PMMA Blocks, FLNT Temp, FLNT Base Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Hyramic CAD/CAM Restorative Glaze Paste, Glaze Powder, and Glaze Liquid Gradual Dental Zirconia Blank Dental Zirconia Blank for Aesthetic Restoration Upcera Coloring Liquid (I and II)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2026-03-03
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2026-03-03
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-06-12
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-06-12
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-12-12
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2018-12-18
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-12-10
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-06-12
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2016-06-12

Official Correspondent

Li Luo

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Shenzhen Upcera Dental Technology 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
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04

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

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3001389926	DENTAL MANUFACTURING SPA	Badia Polesine Rovigo, IT
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR
1410097	GC AMERICA INC.	ALSIP, IL, US
3015396763	MGNEWTON LTD.	Gyengsan-si Gyeongbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012441963. Last updated year: 2026. Please use registration number 3012441963 when referencing this establishment in official correspondence.