Hygedent Inc

FDA Filings

This page includes the latest FDA filings for Hygedent Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3011187729

FEI Number

3011187729

Name

Zoe Sun

Owner & Operator

HYGEDENT INC.

Contact Address

Gate E, Building 1, No.97 Changping Road Shahe Town, Changping District ,
Beijing CN-11 Beijing 102206 CN

Official Correspondent

Peng Wang
86-10-1390128495-6

US Agent

Zoe Sun
Hygedent Dental Inc
858 2614763
zoe.sun@hygedent.com

Importing Logistics Registration

Importer	Hygedent Dental Inc.
Address	5755 Oberlin Drive, Ste 301 San Diego, CA 92121 UNITED STATES

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

11622 El Camino Real, Suite 100
San Diego, CA 92130 US

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K191034 Hygedent Inc.	VPS Impression Material	2019-09-04
PMN K170812 \| ELW Zoe Sun [HYGEDENT INC.]	HygePLUS Alginate Impression Material	2017-12-07
PMN K170812 HYGEDENT INC.	HygePLUS Alginate Impression Material	2017-07-26
PMN K140074 \| ELW Zoe Sun [HYGEDENT INC.]	HYGEPLUS	2014-06-17
PMN K140074 \| ELW Zoe Sun [HYGEDENT INC.]	HYGEMAX	2014-06-17
PMN K140074 \| ELW Zoe Sun [HYGEDENT INC.]	HYGEDENT	2014-06-17
PMN K140074 \| ELW Zoe Sun [HYGEDENT INC.]	HYGECHROMA	2014-06-17
PMN K140074 \| ELW Zoe Sun [HYGEDENT INC.]	CHROMATIC	2014-06-17
PMN K140074 HYGEDENT INC	HYGEDENT ALGINATE IMPRESSION MATERIAL	2014-05-21

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Hygedent Dental Inc

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020070231788	Xingang,China (Mainland) -> Long Beach, California	ALGINATE IMPRESSION MATERIAL	45 PKG
2020010422683	Xingang,China (Mainland) -> Los Angeles, California	ALGINATE IMPRESSION MATERIAL	64 PKG
2019061231182	Pusan,South Korea -> Los Angeles, California	ALGINATE IMPRESSION MATERIAL	1428 PKG
2019012129229	Pusan,South Korea -> Los Angeles, California	ALGINATE IMPRESSION MATERIAL MESUREMENT CUPS AND SCOOP	720 PKG
2018010321461	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	ALGINATE IMPRESSION MATERIAL	120 CTN