Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016096134

FEI Number

3016096134

Entity Name

TBM CORPORATION

City/State/Country

Buk-gu, Gwangju, KR

Establishment Address

B-301, 313, Cheomdangwagi-ro,, Buk-gu, Gwangju 61008, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TBM Corporation (Owner Number: 10061533)

Owner / Operator Contact Address

B-301, 313, Cheomdangwagi-ro,, Buk-gu,, KR-29 61008, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211851

PMA Number

N/A

All Registered Proprietary Names

Canker Relief (Model: CR12) Curatick (Models: CR12, CR23, CR53) OraCare (Models: CR12, OB23, OB53) Ora-Aid (models: OB23, OB53) Augma Shield (model: OB23)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2019-10-27
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2022-02-11
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2022-02-11

Official Correspondent

Jaewoong Jung

US Agent Details

RYAN HWANG Business: INNO SENSE, INC. Email: ryan.s.hwang@hotmail.com Phone: (201) 4319052

Related Public Records

Same Entity

TBM Corporation

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
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**

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3004146122	MAXIGEN BIOTECH, INC.	Taoyuan City, TW
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016096134. Last updated year: 2026. Please use registration number 3016096134 when referencing this establishment in official correspondence.