Meta Biomed Co., Ltd.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Meta Biomed Co., Ltd.” (first 2003, latest 2024), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 96 days. Since 2017 the median was 100 days, against 115 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 132 |
| 2014 | 2 | 214 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 3 | 154 |
| 2019 | 3 | 98 |
| 2020 | 1 | 224 |
| 2021 | 2 | 156 |
| 2022 | 0 | — |
| 2023 | 3 | 59 |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Meta Biomed Co., Ltd. took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | 9 | 9 |
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Review panels
- Dental (22)
- Radiology (2)
- Orthopedic (1)
Most recent Meta Biomed Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242014 | Jet Flow Bulk | EBF | 2024-10-08 | 90 |
| K232299 | CeraPutty | KIF | 2023-09-29 | 59 |
| K230010 | ADSEAL Plus | KIF | 2023-04-13 | 100 |
| K230009 | EZ Bond Universal | KLE | 2023-03-03 | 59 |
| K210904 | Metapaste Plus | KIF | 2021-06-30 | 96 |
| K202617 | Metapex Plus | KIF | 2021-04-14 | 217 |
| K191991 | Ezfil | EBF | 2020-03-05 | 224 |
| K190724 | MD-Temp Plus | EBG | 2019-07-03 | 105 |
| K190503 | CeraSeal | KIF | 2019-06-07 | 98 |
| K190510 | GuttaSil | KIF | 2019-05-29 | 89 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Meta Biomed Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Meta Systems Co., Ltd. (4 510(k)s)
- Meta Health, Inc. (1 510(k)s)
- Meta Imaging Solutions, LLC (1 510(k)s)
- Meta Platform Technologies, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meta Biomed Co., Ltd.?
FDA lists 25 510(k) clearances under the applicant name “Meta Biomed Co., Ltd.” (first 2003, latest 2024), across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Meta Biomed Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meta Biomed Co., Ltd. is 96 days. Since 2017: 100 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Meta Biomed Co., Ltd.?
The most frequent FDA product codes under this applicant name are KIF (Resin, Root Canal Filling, 9); EBF (Material, Tooth Shade, Resin, 4); EBG (Crown And Bridge, Temporary, Resin, 2).
Next steps
- See all 25 Meta Biomed Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KIF, Meta Biomed Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.