Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paxmed International · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113568 | MTA-FILLAPEX | Paxmed International | 2012-08-21 | 263 | 0 |
| K022038 | SPI ONETIME DENTAL IMPLANT | Paxmed International | 2002-07-15 | 21 | 0 |
| K010467 | UNIVERSAL DENTAL COPING (UDC) | Paxmed International | 2001-09-28 | 224 | 0 |
| K011223 | QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM | Paxmed International | 2001-09-20 | 153 | 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