Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Swiss American Metal Craft Corp. · 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) |
|---|---|---|---|---|---|
| K802984 | MEISINGER DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | 1980-12-30 | 39 | 0 |
| K802987 | JOTA DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | 1980-12-30 | 39 | 0 |
| K802988 | JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS | Swiss American Metal Craft Corp. | 1980-12-30 | 39 | 0 |
| K802989 | MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. | Swiss American Metal Craft Corp. | 1980-12-30 | 39 | 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