Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
North American Alloys, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
81 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993344 | P10 SPECIAL | North American Alloys, Inc. | 1999-11-15 | 41 | 0 |
| K873661 | CHROME-COBALT BASE DENTAL ALLOY | North American Alloys, Inc. | 1987-11-16 | 67 | 0 |
| K862930 | PERFECT ONE | North American Alloys, Inc. | 1986-10-24 | 81 | 0 |
| K853845 | ALLOY B | North American Alloys, Inc. | 1985-11-19 | 64 | 0 |
| K853498 | PERFECT 10 | North American Alloys, Inc. | 1985-09-27 | 38 | 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