Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Talladium, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
230 daysmedian FDA review time
422 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152023 | Luminesse Shaded Zirconia SZ | Talladium, Inc. | 2016-09-15 | 422 | 0 |
| K152066 | Luminesse Anterior Zirconia AT | Talladium, Inc. | 2015-10-21 | 89 | 0 |
| K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID | Talladium, Inc. | 2015-06-15 | 230 | 0 |
| K142371 | Luminesse PMMA | Talladium, Inc. | 2015-04-24 | 242 | 0 |
| K140848 | LUMINESSE PORCELAIN SYSTEM | Talladium, Inc. | 2014-12-17 | 258 | 0 |
| K100232 | LUMINESSE ZR BLANKS | Talladium, Inc. | 2010-05-21 | 115 | 0 |
| K894085 | TALLADIUM TILITE CERAMIC ALLOY | Talladium, Inc. | 1989-12-20 | 195 | 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