Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zirkonzahn Srl — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
209 daysmedian FDA review time
475 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232691 | Polibond | Zirkonzahn Srl | 2023-09-05 | 4 | 0 |
| K213722 | ICE Ceramics, ICE Stains, Fresco | Zirkonzahn Srl | 2022-12-14 | 383 | 0 |
| K203765 | ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Pract | Zirkonzahn Srl | 2021-07-20 | 209 | 0 |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Zirkonzahn Srl | 2020-07-08 | 114 | 0 |
| K190518 | Color Liquid, Vita Liquid | Zirkonzahn Srl | 2019-11-22 | 263 | 0 |
| K183304 | Prettau, ICE, Z-White zirconia blanks | Zirkonzahn Srl | 2019-04-04 | 127 | 0 |
| K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tec | Zirkonzahn Srl | 2018-06-18 | 13 | 0 |
| K132230 | ICE ZIRKON TRANSLUZENT | Zirkonzahn Srl | 2014-11-05 | 475 | 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