Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Matech, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
434 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010069 | DURABOND NON-PRECIOUS CERAMIC ALLOY | Matech, Inc. | 2001-02-15 | 38 | 0 |
| K993572 | CERADIUM V NON-PRECIOUS CERAMIC ALLOY | Matech, Inc. | 1999-12-13 | 53 | 0 |
| K992881 | HI BOND NON-PRECIOUS CERAMIC ALLOY | Matech, Inc. | 1999-11-19 | 85 | 0 |
| K992705 | CERADIUM NON-PRECIOUS CERAMIC ALLOY | Matech, Inc. | 1999-09-22 | 42 | 0 |
| K974894 | KROMATICA COLOR CHANGING ALGINATE | Matech, Inc. | 1998-02-12 | 43 | 0 |
| K925746 | REPLICA | Matech, Inc. | 1994-01-21 | 434 | 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