Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Vita Zahnfabrik H.Rauter GmbH & Co. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
212 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. | 2025-02-21 | 63 | 0 |
| K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. | 2018-08-01 | 135 | 0 |
| K153645 | VITA ENAMIC Implant Solutions (IS) | Vita Zahnfabrik H.Rauter GmbH Co. | 2016-06-30 | 192 | 0 |
| K152373 | VITA VM LC Flow | Vita Zahnfabrik H.Rauter GmbH & Co. | 2015-12-30 | 131 | 0 |
| K132070 | VITA SUPRINITY(R) | Vita Zahnfabrik H.Rauter GmbH & Co. | 2014-01-31 | 212 | 0 |
| K122269 | ENAMIC | Vita Zahnfabrik H.Rauter GmbH & Co. | 2012-12-13 | 136 | 0 |
| K102128 | VITABLOCS | Vita Zahnfabrik H.Rauter GmbH & Co. | 2010-08-11 | 13 | 0 |
| K090644 | VITABLOCS, MODEL VX55-**** | Vita Zahnfabrik H.Rauter GmbH & Co. | 2009-03-31 | 21 | 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