Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kat Implants, LLC · 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) |
|---|---|---|---|---|---|
| K112758 | KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 | Kat Implants, LLC | 2012-02-23 | 154 | 0 |
| K101201 | STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT | Kat Implants, LLC | 2011-04-13 | 349 | 0 |
| K083544 | KAT IMPLANT SYSTEM | Kat Implants, LLC | 2009-02-02 | 66 | 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