Manufacturer registered with FDA

HRS Co., Ltd.

Pyongtaek, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10035700Manufacturer

Device types listed: 1
Brands and models: 7
510(k) clearances: 22014–2018
Markets registered in: 32 registrations outside the US
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name HRS Co., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: South KoreaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	HRS Co., Ltd.	2 clearances	2014–2018	Below
Brazil	ANVISA	Manufacturer	HRS Co., Ltd	1	2017–2017	Pure Global AI
Taiwan	TFDA	Manufacturer	HRS CO., LTD	1	2017–2017	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What HRS Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Impression MaterialELW · Class 2	Impression materials	Maker	Sildent BiteSildent Fast Heavy BodySildent Fast Light BodySILDENT HEAVY BODYSILDENT LIGHT BODYSILDENT PUTTYSILDENT REGULAR BODY	2014

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names HRS Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
28 Nov 2018	K181604	Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite	ELW Impression Material
19 Jun 2014	K132869	SILDENT	ELW Impression Material

Registered establishments

Establishment	Location	What it does
HRS CO., LTD.FDA reg. 3008895253	Pyongtaek Gyeonggi, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10035700). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.