Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
The Stern Metals Co., Inc. · 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) |
|---|---|---|---|---|---|
| K962301 | STERNGOLD G-HARD METAL ALLOY | The Stern Metals Co., Inc. | 1996-07-18 | 31 | 0 |
| K933193 | IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,L | The Stern Metals Co., Inc. | 1994-03-07 | 250 | 0 |
| K926305 | IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER | The Stern Metals Co., Inc. | 1994-03-01 | 441 | 0 |
| K924219 | ENDOSSEOUS IMPLANTS | The Stern Metals Co., Inc. | 1994-02-14 | 542 | 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