Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015332784

FEI Number

3015332784

Entity Name

OSSTEM IMPLANT CO., LTD.

City/State/Country

SIHEUNG Gyeonggi, KR

Establishment Address

A-DONG, 51, MAYU-RO 238BEON-GIL, SIHEUNG Gyeonggi 15079, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSSTEM IMPLANT CO LTD (Owner Number: 9062743)

Owner / Operator Contact Address

66-16, Bansong-ro 513beon-gil,, Haeundae-gu, KR-26 48002, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HySil Plus Impression Materials HySil Super Fast Impression Material Hysil Impression Material SUFLEX 50ML Impression Gun OSSTEM Mixing Tip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELW	Material, Impression	Dental	Class 2	872.3660	2021-06-02
ELW	Material, Impression	Dental	Class 2	872.3660	2020-01-30
ELW	Material, Impression	Dental	Class 2	872.3660	2017-06-15
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2019-04-04

Official Correspondent

No official correspondent registered.

US Agent Details

Martin Shin Business: HIOSSEN, Inc. Email: regulatoryaffairs@hiossen.com Phone: (267) 7106714

Related Public Records

Same Entity

OSSTEM IMPLANT CO LTD

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003394081	OSSTEM IMPLANT CO., LTD.	Haeundae-gu Busan, KR

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 3015332784. Last updated year: 2026. Please use registration number 3015332784 when referencing this establishment in official correspondence.