Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meta Biomed Co., Ltd. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
217 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242014 | Jet Flow Bulk | Meta Biomed Co., Ltd. | 2024-10-08 | 90 | 0 |
| K232299 | CeraPutty | Meta Biomed Co., Ltd. | 2023-09-29 | 59 | 0 |
| K230010 | ADSEAL Plus | Meta Biomed Co., Ltd. | 2023-04-13 | 100 | 0 |
| K230009 | EZ Bond Universal | Meta Biomed Co., Ltd. | 2023-03-03 | 59 | 0 |
| K210904 | Metapaste Plus | Meta Biomed Co., Ltd. | 2021-06-30 | 96 | 0 |
| K202617 | Metapex Plus | Meta Biomed Co., Ltd. | 2021-04-14 | 217 | 0 |
| K191991 | Ezfil | Meta Biomed Co., Ltd. | 2020-03-05 | 224 | 0 |
| K190724 | MD-Temp Plus | Meta Biomed Co., Ltd. | 2019-07-03 | 105 | 0 |
| K190503 | CeraSeal | Meta Biomed Co., Ltd. | 2019-06-07 | 98 | 0 |
| K190510 | GuttaSil | Meta Biomed Co., Ltd. | 2019-05-29 | 89 | 0 |
| K181689 | Nexcomp | Meta Biomed Co., Ltd. | 2018-11-15 | 142 | 0 |
| K180802 | Meta P&Bond | Meta Biomed Co., Ltd. | 2018-08-29 | 154 | 0 |
| K171449 | Metacem | Meta Biomed Co., Ltd. | 2018-05-15 | 363 | 0 |
| K081913 | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER | Meta Biomed Co., Ltd. | 2008-09-05 | 64 | 0 |
| K080772 | BONEMEDIK-DM | Meta Biomed Co., Ltd. | 2008-06-03 | 76 | 0 |
| K080305 | NEXCOMP AND META ETCHANT | Meta Biomed Co., Ltd. | 2008-04-07 | 62 | 0 |
| K070897 | BONEMEDIK, AND BONEMEDIK-S | Meta Biomed Co., Ltd. | 2007-09-17 | 168 | 0 |
| K061530 | MD-TEMP | Meta Biomed Co., Ltd. | 2006-07-21 | 49 | 0 |
| K042769 | ADSEAL ROOT CANAL SEALER | Meta Biomed Co., Ltd. | 2004-11-24 | 50 | 0 |
| K032605 | METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY RO | Meta Biomed Co., Ltd. | 2003-10-08 | 44 | 0 |
| K032603 | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL | Meta Biomed Co., Ltd. | 2003-10-07 | 43 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda