Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentaurum — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
266 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062733 | TOMAS PIN SD 6, 8, AND 10 MM | Dentaurum | 2006-11-09 | 57 | 0 |
| K062732 | TOMAS PIN 6 MM | Dentaurum | 2006-10-25 | 42 | 0 |
| K030644 | CONTEC DUO, CONTEC LC, CONTEC LCR | Dentaurum | 2003-11-21 | 266 | 0 |
| K032195 | DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT | Dentaurum | 2003-10-07 | 81 | 0 |
| K030980 | DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE | Dentaurum | 2003-08-25 | 150 | 0 |
| K030977 | DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE | Dentaurum | 2003-08-25 | 150 | 0 |
| K030641 | CONTEC LIGHT | Dentaurum | 2003-06-10 | 102 | 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