Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009130085

FEI Number

3009130085

Entity Name

BioMTA

City/State/Country

Daejeon, KR

Establishment Address

41, Techno 8-ro, Yuseong-gu, Daejeon 34028, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioMTA (Owner Number: 10034152)

Owner / Operator Contact Address

41, Techno 8-ro, Yuseong-gu, Daejeon, KR-30 34028, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MTA Syringer OrthoMTA Carrier Uitrasonic Endo TIP OrhtoMTA Compactor OrthoMTA(Mineral Trioxide Aggregate) OrthoMTA Mixer OrthoMTA Needle Tips MTA Syringer Tips OrhtoMTA Plugger

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2013-02-25
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2016-12-22
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2013-02-25
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2010-11-10
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2013-02-25
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2013-02-25

Official Correspondent

Jun-sang Yoo

US Agent Details

Sunyoung Park Email: sypark@szukorea.com Phone: (682) 7729233

Related Public Records

Same Entity

BioMTA

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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27

Similar Registrations

Registration Number	Establishment Name	Location
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3001620590	TECHNIMEN SKILLERS	SIALKOT Punjab, PK
3001644167	Symmetry Surgical GmbH	TUTTLINGEN Baden-Wurttemberg, DE
2511556	PREMIER DENTAL PRODUCTS CO.	PLYMOUTH MEETING, PA, US
3021023132	WUXI LYUSMILE IMP AND EXP CO.,LTD	WUXI Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009130085. Last updated year: 2026. Please use registration number 3009130085 when referencing this establishment in official correspondence.