Company ยท KR
Meta Biomed Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2024. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KIF | Resin, Root Canal Filling | 9 |
| EBF | Material, Tooth Shade, Resin | 4 |
| EBG | Crown And Bridge, Temporary, Resin | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 |
| EMA | Cement, Dental | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 |
| ELW | Material, Impression | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2024 | K242014 | Jet Flow Bulk Meta Biomed Co., Ltd., KR | EBF |
| Sep 29, 2023 | K232299 | CeraPutty Meta Biomed Co., Ltd., KR | KIF |
| Apr 13, 2023 | K230010 | ADSEAL Plus Meta Biomed Co., Ltd., KR | KIF |
| Mar 3, 2023 | K230009 | EZ Bond Universal Meta Biomed Co., Ltd., KR | KLE |
| Jun 30, 2021 | K210904 | Metapaste Plus Meta Biomed Co., Ltd., KR | KIF |
| Apr 14, 2021 | K202617 | Metapex Plus Meta Biomed Co., Ltd., KR | KIF |
| Mar 5, 2020 | K191991 | Ezfil Meta Biomed Co., Ltd., KR | EBF |
| Jul 3, 2019 | K190724 | MD-Temp Plus Meta Biomed Co., Ltd., KR | EBG |
| Jun 7, 2019 | K190503 | CeraSeal Meta Biomed Co., Ltd., KR | KIF |
| May 29, 2019 | K190510 | GuttaSil Meta Biomed Co., Ltd., KR | KIF |
| Nov 15, 2018 | K181689 | Nexcomp Meta Biomed Co., Ltd., KR | EBF |
| Aug 29, 2018 | K180802 | Meta P&Bond Meta Biomed Co., Ltd., KR | KLE |
| May 15, 2018 | K171449 | Metacem Meta Biomed Co., Ltd., KR | EMA |
| Sep 19, 2014 | K133298 | ENDO SMART Meta Biomed, Inc. | EKX |
| Apr 9, 2014 | K134008 | MD-FLEX HEAVY BODY Meta Biomed, Inc. | ELW |
| Jul 31, 2013 | K132041 | REXTAR X Meta Biomed, Inc. | EHD |
| Mar 1, 2013 | K122016 | REXTAR, REXTAR LCD Meta Biomed, Inc. | EHD |
| Sep 5, 2008 | K081913 | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER Meta Biomed Co., Ltd., KR | EMA |
| Jun 3, 2008 | K080772 | BONEMEDIK-DM Meta Biomed Co., Ltd., KR | LYC |
| Apr 7, 2008 | K080305 | NEXCOMP AND META ETCHANT Meta Biomed Co., Ltd., KR | EBF |
| Sep 17, 2007 | K070897 | BONEMEDIK, AND BONEMEDIK-S Meta Biomed Co., Ltd., KR | MQV |
| Jul 21, 2006 | K061530 | MD-TEMP Meta Biomed Co., Ltd., KR | EBG |
| Nov 24, 2004 | K042769 | ADSEAL ROOT CANAL SEALER Meta Biomed Co., Ltd. | KIF |
| Oct 8, 2003 | K032605 | METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING Meta Biomed Co., Ltd. | KIF |
| Oct 7, 2003 | K032603 | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING Meta Biomed Co., Ltd. | KIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||