Biomta

FDA Filings

This page includes the latest FDA filings for Biomta. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3009130085

FEI Number

3009130085

Name

Priscilla Chung

Owner & Operator

BioMTA

Contact Address

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

Official Correspondent

Jun-sang Yoo
82-2-8853923-x

US Agent

Priscilla Chung
LK Consulting Group USA, Inc.
714 2025789
juhee.c@lkconsultinggroup.com

Importing Logistics Registration

Importer	Augeo Solutions Inc.
Address	3015 Kaiser Drive #G Santa Clara, CA 95051 UNITED STATES
Importer Type	Retailer

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

1150 Roosevelt, STE 200
Irvine, CA 92620 US

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800027200115 BioMTA	Ultrasonic Tip 0.5mm (BUST-05)	2024-04-10
GUDID 08800027200108 BioMTA	Ultrasonic Tip 0.3mm (BUST-03)	2024-04-10
GUDID 08800027200092 BioMTA	Ultrasonic Tip CM (BUST-CM)	2024-04-10
GUDID 08800027200085 BioMTA	OrhtoMTA Needle Tips	2024-04-10
GUDID 08800027200078 BioMTA	OrthoMTA	2024-04-10
GUDID 08800027200061 BioMTA	OrthoMTA	2024-04-10
GUDID 08800027200054 BioMTA	RetroMTA(RetroMTA-OrthoMTAII)	2024-04-10
GUDID 08800027200047 BioMTA	RetroMTA(RetroMTA-OrthoMTAII)	2024-04-10
GUDID 08800027200030 BioMTA	SmartMTA	2024-04-10
GUDID 08800027200023 BioMTA	Smart MTA	2024-04-10
EMN Priscilla Chung [BioMTA]	Uitrasonic Endo TIP	2016-12-22
EKN Priscilla Chung [BioMTA]	Bio Paperpoint	2016-12-22
PMN K132825 \| KIF Priscilla Chung [BioMTA]	Smart MTA	2014-04-14
PMN K132825 \| KIF Priscilla Chung [BioMTA]	RetroMTA-OrthoMTA II	2014-04-14
PMN K132825 BIOMTA	RETROMTA-ORTHOMTA II	2014-04-10
EKS Priscilla Chung [BioMTA]	OrhtoMTA Compactor	2013-02-25
EKR Priscilla Chung [BioMTA]	OrhtoMTA Plugger	2013-02-25
EKK Priscilla Chung [BioMTA]	OrthoMTA Carrier	2013-02-25
EKK Priscilla Chung [BioMTA]	MTA Syringer	2013-02-25
EIY Priscilla Chung [BioMTA]	OrthoMTA Needle Tips	2013-02-25
EIY Priscilla Chung [BioMTA]	OrthoMTA Mixer	2013-02-25
EIY Priscilla Chung [BioMTA]	MTA Syringer Tips	2013-02-25
PMN K102575 \| KIF Priscilla Chung [BioMTA]	OrthoMTA(Mineral Trioxide Aggregate)	2010-11-10

Related Finance Registrations

NCAGE Code	754FF	BIOMTA
CAGE Code	754FF	BIOMTA
S.A.M. Registration	754FF [688731057]	BIOMTA