Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Degussa - Ney Dental, 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) |
|---|---|---|---|---|---|
| K013230 | CERCON BASE | Degussa - Ney Dental, Inc. | 2001-10-25 | 28 | 0 |
| K011333 | CERCON CERAM | Degussa - Ney Dental, Inc. | 2001-08-20 | 110 | 0 |
| K993514 | DEFINITE | Degussa - Ney Dental, Inc. | 2000-02-24 | 129 | 0 |
| K993897 | CERGOGOLD | Degussa - Ney Dental, Inc. | 2000-01-10 | 55 | 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