Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006946041

FEI Number

3006946041

Entity Name

OSSTEM ORTHODONTICS Inc.

City/State/Country

Uiwang-si Gyeonggi, KR

Establishment Address

(Ojeon-dong, Byeoksantechnopia) A-1203, 1204, 13 Ojeongongeop-gil,, Uiwang-si Gyeonggi 16072, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OSSTEM ORTHODONTICS Inc. (Owner Number: 10050607)

Owner / Operator Contact Address

(Ojeon-dong, Byeoksantechnopia) A-1203, 1204, 13 Ojeongongeop-gil,, Uiwang-si, KR-41 16072, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FACEMASK BL Rev BK MASK violet BK MASK ivory BK MASK blue FACEMASK BL Org FACEMASK VI Org FACEMASK VI Rev Sensation Genesis- C Clear Elect MAJESTY-SLC Neocrystal Plus Pure MTA Silver Tube 3mm MTA One side flattened Tube MTA Round Tube MTA Silver Tube 2mm MTA Semi-Round Tube L-Tube 2mm LPA 027 tube 2mm L-Tube 3mm LPA 022 tube 3mm LPA 022 tube 1mm LPA 027 tube 3mm LPA 022 tube 2mm LPA 027 tube 1mm Sensation M YES2 MAJESTY-SLM SM Tube MAJESTY Tube Dr. Unbong's M-P Tube(Molar Protraction Tube) 650-12 Reducer Strip(One-side) 650-10 Reducer Strip(Thin) 650-09 Reducer Strip(Thick) 650-08 Perforated Strip MTA Wire 012 NiTi MTA Wire 014 NiTi MTA Wire 45celsius thermo-active 012 NiTi MTA Wire 40celsius thermo-active 012 NiTi MTA Wire 35celsius thermo-active 012 NiTi

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2021-10-27
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2016-07-27
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2016-07-27
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2015-12-08
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2016-07-27
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2024-04-18
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2015-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

Grace Kim Business: J.S.Chem International Co. Email: gracejschem@hotmail.com Phone: (310) 5983012

Related Public Records

Same Entity

OSSTEM ORTHODONTICS Inc.

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
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

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2126683	AMERICAN ORTHODONTICS	SHEBOYGAN, WI, US
3026326493	ZHEJIANG YAMEI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.	Yang Jiao Lang Zin'an Town Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006946041. Last updated year: 2026. Please use registration number 3006946041 when referencing this establishment in official correspondence.