Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008895253

FEI Number

3008957253

Entity Name

HRS CO., LTD.

City/State/Country

Pyongtaek Gyeonggi, KR

Establishment Address

7, Chupalsandan 2-gil, Paengseong-eup, Pyongtaek Gyeonggi 17998, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HRS Co., Ltd. (Owner Number: 10035700)

Owner / Operator Contact Address

7, Chupalsandan 2-gil, Paengseong-eup, Pyongtaek, KR-41 17998, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181604

PMA Number

N/A

All Registered Proprietary Names

SILDENT REGULAR BODY SILDENT PUTTY SILDENT HEAVY BODY SILDENT LIGHT BODY Sildent Fast Light Body Sildent Fast Heavy Body Sildent Bite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2014-12-10
ELW	Material, Impression	Dental	Class 2	872.3660	2020-12-08

Official Correspondent

SHENGHWAN GO

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

HRS 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 3008895253. Last updated year: 2026. Please use registration number 3008895253 when referencing this establishment in official correspondence.