Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681254

FEI Number

3005907356

Entity Name

META BIOMED CO., LTD.

City/State/Country

Cheongju-si Chungbuk, KR

Establishment Address

270, Osongsaengmyeong 1-ro, Osong-eup,Heungdeok-gu, Cheongju-si Chungbuk 28161, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Meta Biomed Co, Ltd (Owner Number: 9021123)

Owner / Operator Contact Address

3015 Advance Ln, Colmar, PA 18915, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230010

PMA Number

N/A

All Registered Proprietary Names

Meta P&Bond MD-Temp EZ Bond Universal Meta Etchant Nexcomp Flow Ezfil ADSEAL Metapex Plus CeraPutty MD-Temp Plus MD-Cleanser MD-ChelCream Jet Flow Bulk Aurum Metapaste Metacem Metapaste Plus Meta Clip-P Applier Plus ADSEAL Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2018-10-22
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2009-02-10
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-03-09
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-07-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-07-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-03-08
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2009-02-10
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-04-14
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2023-10-30
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2019-07-09
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2002-05-30
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2024-11-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-11-11
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2017-05-16
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2008-07-11
EMA	Cement, Dental	Dental	Class 2	872.3275	2018-05-29
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2021-07-01
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2022-04-26
ELW	Material, Impression	Dental	Class 2	872.3660	2019-11-14
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2023-04-18

Official Correspondent

Ian Yun

US Agent Details

Ian Yun Business: Meta Biomed Inc. Email: ian@metabiomed-inc.com Phone: (267) 2825893

Related Public Records

Same Entity

Meta Biomed Co, Ltd

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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681254. Last updated year: 2026. Please use registration number 9681254 when referencing this establishment in official correspondence.