Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Alliage S/A Industrias Médico Odontológica · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR6 | Alliage S/A Industrias Médico Odontológica | 2024-01-03 | 92 | 0 |
| K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontológica | 2023-04-07 | 108 | 0 |
| K210820 | EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontológica | 2021-08-10 | 144 | 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