Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pro3Dure Medical GmbH · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212017 | Thermeo System | Pro3Dure Medical GmbH | 2022-04-08 | 284 | 0 |
| K211415 | GR Splint Resin System | Pro3Dure Medical GmbH | 2021-10-21 | 168 | 0 |
| K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021-05-05 | 91 | 0 |
| K201827 | GR-17 Resin System | Pro3Dure Medical GmbH | 2020-11-05 | 126 | 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