Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004605596

FEI Number

3004605596

Entity Name

HANDAE CHEMICAL CO., LTD

City/State/Country

Jincheon-gun Chungbuk, KR

Establishment Address

56-28, Songdu 4-gil, Jincheon-eup, Jincheon-gun Chungbuk 27845, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Handae Chemical Co., Ltd (Owner Number: 10035933)

Owner / Operator Contact Address

56-28, Songdu 4-gil, Jincheon-eup, Jincheon-gun, KR-43 27845, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Delikit Bite Registration Premium PERFECT-F VPS PUTTY VINYLATE PERFECT-F VPS REGULAR BODY PERFECT-F VPS HEAVY BODY PERFECT-F VPS FIT CHECKER PERFECT-F VPS LIGHT BODY PERFECT BITE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2024-09-15
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2011-04-05

Official Correspondent

No official correspondent registered.

US Agent Details

Krallum Uju Business: Onbix Corp US Email: onbixus@gmail.com Phone: (843) 5828036

Related Public Records

Same Entity

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

Similar Registrations

Registration Number	Establishment Name	Location
3030268763	OWL DENTAL	San Leandro, CA, US
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 3004605596. Last updated year: 2026. Please use registration number 3004605596 when referencing this establishment in official correspondence.