Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Envisiontec GmbH — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
210 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220894 | SmileGuard | Envisiontec GmbH | 2022-06-10 | 74 | 0 |
| K211101 | E-Temp | Envisiontec GmbH | 2021-06-14 | 62 | 0 |
| K210977 | E-Dent 1000 | Envisiontec GmbH | 2021-05-25 | 54 | 0 |
| K203641 | E-Denture Pro | Envisiontec GmbH | 2021-03-30 | 106 | 0 |
| K201173 | E-Guard | Envisiontec GmbH | 2020-11-27 | 210 | 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