Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017619362

FEI Number

3017619362

Entity Name

SHENZHEN UP3D TECH CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

401, Block B, Nanshan Yungu Nanfeng Tower, 4093 Liuxian Avenue, Nanshan District, Shenzhen Guangdong 518055, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen UP3D Tech Co., Ltd. (Owner Number: 10078226)

Owner / Operator Contact Address

401, Block B, Nanshan Yungu Nanfeng Tower, 4093 Liuxian Avenue, Nanshan District,, Shenzhen, CN-GD 518055, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

POWDER, PORCELAIN-Dental Zirconia Blocks 3D Scanner,UP300E 3D Scanner,UP560HD Intraoral ScannerUP600,UP610 3D Scanner,UP300PM 3D Scanner,UP500 3D Scanner,UP560 (H. M) 3D Scanner,UP360 3D Scanner,UP300 3D Scanner,UP200 3D Scanner,UP300PH 3D Scanner, UP1000 3D Scanner,UP300S 3D Scanner, UP400 3D Scanner,UP560ProH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-01-20
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2020-10-15

Official Correspondent

Nerella Xiong

US Agent Details

Xiong Nerella Business: UP3D TECH (USA) INC Email: baoyi@up3dtech.com Phone: (626) 5595426

Related Public Records

Same Entity

Shenzhen UP3D Tech 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 3017619362. Last updated year: 2026. Please use registration number 3017619362 when referencing this establishment in official correspondence.