Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034729565

FEI Number

3034729565

Entity Name

DEPRAG HIGH TECH MATERIALS ( ZHENGZHOU ) CO.,LTD.

City/State/Country

ZHANGZHOU Henan, CN

Establishment Address

No.101,1st Floor,Building 12,No.8 Jinzhan Street,High-tech Industrial Development Zone,, ZHANGZHOU Henan 450066, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. (Owner Number: 10092180)

Owner / Operator Contact Address

No.101,1st Floor,Building 12,No.8 Jinzhan Street,High-tech Industrial Development Zone,, ZHANGZHOU, CN-HA 450066, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Zirconia Ceramic Diamond burs Dental Model Materials Light Cure Composite Resin NiTi-File Firing paste Synthetic resin teeth

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-12-12
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2025-12-23
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2025-07-21
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2025-12-23
EJS	Alloy, Other Noble Metal	Dental	Class 2	872.3060	2025-12-23
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2025-12-23

Official Correspondent

Junfei Mao

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (509) 5816099

Related Public Records

Same Entity

DEPRAG High tech Materials ( Zhengzhou ) 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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

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
3013513796	Orbray Co., Ltd.	Yokote-shi Akita, JP
3034729999	LIAONING RACHCERA MATERIAL TECHNOLOGY CO.,LTD.	Shenyang Liaoning, CN
3021284321	ZIRDENT NEW MATERIAL CO.,LTD	Changsha Hunan, CN
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 3034729565. Last updated year: 2026. Please use registration number 3034729565 when referencing this establishment in official correspondence.