Pro3Dure Medical GmbH: FDA clearances and approvals
Pro3Dure Medical GmbH has 5 FDA 510(k) clearances (first 2020, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time: 168 days. Since 2017 its median was 168 days, against 143 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 126 |
| 2021 | 2 | 130 |
| 2022 | 1 | 284 |
| 2023 | 0 | — |
| 2024 | 1 | 419 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Pro3Dure Medical GmbH's cleared 510(k)s took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQC | Mouthguard, Prescription | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
Review panels
- Dental (5)
Most recent Pro3Dure Medical GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231775 | GR Resin System MSI | MQC | 2024-08-08 | 419 |
| K212017 | Thermeo System | MQC | 2022-04-08 | 284 |
| K211415 | GR Splint Resin System | MQC | 2021-10-21 | 168 |
| K210298 | GR-14 Resin System | EBI | 2021-05-05 | 91 |
| K201827 | GR-17 Resin System | EBG | 2020-11-05 | 126 |
Recalls
openFDA lists no recalls under a recalling firm named Pro3Dure Medical GmbH.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pro3Dure Medical GmbH have?
Pro3Dure Medical GmbH has 5 FDA 510(k) clearances (first 2020, latest 2024), across 3 product codes in 1 review panel.
How long does FDA take to clear Pro3Dure Medical GmbH's 510(k)s?
The median time from FDA receipt to decision across Pro3Dure Medical GmbH's cleared 510(k)s is 168 days. Since 2017: 168 days, versus 143 days for all cleared 510(k)s in the same product codes.
What devices does Pro3Dure Medical GmbH make?
Its most frequent FDA product codes are MQC (Mouthguard, Prescription, 3); EBG (Crown And Bridge, Temporary, Resin, 1); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1).
Has Pro3Dure Medical GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Pro3Dure Medical GmbH. Related entities may recall under other names.
Next steps
- See all 5 Pro3Dure Medical GmbH clearances with predicates and recalls
- Run predicate analysis for product code MQC, Pro3Dure Medical GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.