Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kavo America Corporation · 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) |
|---|---|---|---|---|---|
| K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | Kavo America Corporation | 2005-08-02 | 334 | 0 |
| K050744 | KAVO ERGOCOM/ERGOCAM | Kavo America Corporation | 2005-04-21 | 30 | 0 |
| K042872 | RONDOFLEX PLUS 360 | Kavo America Corporation | 2004-11-23 | 36 | 0 |
| K033221 | KAVO EVEREST ZH-BLANK | Kavo America Corporation | 2003-10-28 | 25 | 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