Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003637055

FEI Number

3003637055

Entity Name

PEARL DENT CO., LTD.

City/State/Country

HOCHIMINH CITY Ho Chi Minh, VN

Establishment Address

LOT III -15B STREET NO.13, TAN BINH INDUSTRIAL PARK, TAY THANH WARD, HOCHIMINH CITY Ho Chi Minh 700000, VN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PEARL DENT CO., LTD. (Owner Number: 9049920)

Owner / Operator Contact Address

LOT III-15B STREET NO.13,, TAN BINH INDUSTRIAL PARK, TAN PHU DISTRICT, HOCHIMINH CITY, VN-NOTA 700000, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKM	Gutta-Percha	Dental	Class 1	872.3850	2002-02-26
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2002-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

PEARL DENT CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3043750057	JIANGSU YIDA MEDICAL EQUIPMENT CO., LTD	Yancheng Jiangsu, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3005831677	B&L BIOTECH CO., INC	Ansan City Gyeonggi, KR
3042866301	HSG-S CORP	Savannah, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003637055. Last updated year: 2026. Please use registration number 3003637055 when referencing this establishment in official correspondence.