Data / Medical devices / South Korea / Meta Biomed Co., Ltd.
Meta Biomed Co., Ltd.: FDA-registered device maker in Cheongju-si Chungbuk, South Korea, 18 510(k) clearances
Meta Biomed Co., Ltd. is registered with the FDA (registration 9681254) in Cheongju-si Chungbuk, South Korea. It lists 14 device types. The FDA files 18 510(k) clearances under its listings, the newest dated October 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681254
- FEI number
- 3005907356
- Address
- 270, Osongsaengmyeong 1-ro, Osong-eup,Heungdeok-gu, Cheongju-si Chungbuk, South Korea, 28161
- Owner or operator
- Meta Biomed Co, Ltd (9021123)
- Roles
- Foreign private label distributor, Manufacturer
- First device listed
- June 27, 1995
- Registered through
- 2026
- Brand names listed
- ADSEAL, ADSEAL Plus, Absorbent Paper Points, Aurum, BoneMedik-DM, CeraPutty, CeraSeal, EZ Bond Universal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Applier, Surgical, Clip | GDO | 1 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Foreign private label distributor | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Point, Paper, Endodontic | EKN | 1 | Manufacturer | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 8, 2024 | K242014 | Jet Flow Bulk | EBF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| September 29, 2023 | K232299 | CeraPutty | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| April 13, 2023 | K230010 | ADSEAL Plus | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| March 3, 2023 | K230009 | EZ Bond Universal | KLE | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| June 30, 2021 | K210904 | Metapaste Plus | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| April 14, 2021 | K202617 | Metapex Plus | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| March 5, 2020 | K191991 | Ezfil | EBF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| July 3, 2019 | K190724 | MD-Temp Plus | EBG | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| June 7, 2019 | K190503 | CeraSeal | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| November 15, 2018 | K181689 | Nexcomp | EBF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| August 29, 2018 | K180802 | Meta P&Bond | KLE | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| May 15, 2018 | K171449 | Metacem | EMA | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| June 3, 2008 | K080772 | BONEMEDIK-DM | LYC | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| April 7, 2008 | K080305 | NEXCOMP AND META ETCHANT | EBF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| July 21, 2006 | K061530 | MD-TEMP | EBG | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| November 24, 2004 | K042769 | ADSEAL ROOT CANAL SEALER | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| October 8, 2003 | K032605 | METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
| October 7, 2003 | K032603 | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of File, Pulp Canal, Endodontic
- All makers of Resin, Root Canal Filling
- All makers of Agent, Tooth Bonding, Resin
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Material, Tooth Shade, Resin
- All makers of Cement, Dental
Updated October 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.