Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011187729

FEI Number

3011187729

Entity Name

HYGEDENT INC.

City/State/Country

Beijing, CN

Establishment Address

Gate E, Building 1, No.97 Changping Road, Shahe Town, Changping District, Beijing 102206, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

HYGEDENT INC. (Owner Number: 10047045)

Owner / Operator Contact Address

Gate E, Building 1, No.97 Changping Road,, Shahe Town, Changping District ,, Beijing, CN-BJ 102206, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170812

PMA Number

N/A

All Registered Proprietary Names

VPS Impression Material VPS Impression Material HygePLUS Alginate Impression Material

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2021-12-01
ELW	Material, Impression	Dental	Class 2	872.3660	2021-12-01
ELW	Material, Impression	Dental	Class 2	872.3660	2017-12-07

Official Correspondent

Peng Wang

US Agent Details

Zoe Sun Business: Hygedent Dental Inc Email: zoe.sun@hygedent.com Phone: (858) 2614763

Related Public Records

Same Entity

HYGEDENT 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
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13

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8021038	VANNINI DENTAL INDUSTRY SRL	GRASSINA(FI) Firenze, IT
2018957	DEN-MAT HOLDINGS, LLC	Lompoc, CA, US
3005558160	MAXILL, INC.	ST. THOMAS Ontario, CA
9611385	Solventum Germany GmbH	SEEFELD Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011187729. Last updated year: 2026. Please use registration number 3011187729 when referencing this establishment in official correspondence.