Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Heraeus Kulzer, LLC (Mitsui Chemicals Group) · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160049 | Charisma | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | 2016-11-15 | 309 | 0 |
| K150933 | iBond Universal & iBond Ceramic Primer | Heraeus Kulzer, LLC, Mitsui Chemicals Group | 2015-07-07 | 92 | 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