PRO3DURE Medical GmbH
Iserlohn North Rhine-Westphalia, DE
PRO3DURE MEDICAL GMBH appears in FDA device records in Iserlohn North Rhine-Westphalia, DE. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for PRO3DURE Medical GmbH between 2020 and 2024. The busiest year on record is 2021, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231775 | GR Resin System MSI | MQC | Substantially Equivalent | |
| K212017 | Thermeo System | MQC | Substantially Equivalent | |
| K211415 | GR Splint Resin System | MQC | Substantially Equivalent | |
| K210298 | GR-14 Resin System | EBI | Substantially Equivalent | |
| K201827 | GR-17 Resin System | EBG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014888923 | 3014888923 | PRO3DURE MEDICAL GMBH | Am Burgberg 13, Iserlohn North Rhine-Westphalia 58642 DE | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- PZYAdditively Manufactured, Preformed, Resin Denture Tooth
- EBGCrown And Bridge, Temporary, Resin
- ESDHearing Aid, Air-Conduction, Prescription
- LDGKit, Earmold, Impression
- DYTMaintainer, Space Preformed, Orthodontic
- EBHMaterial, Impression Tray, Resin
- MQCMouthguard, Prescription
- EEAPlate, Base, Shellac
- KMYPositioner, Tooth, Preformed
- EBIResin, Denture, Relining, Repairing, Rebasing
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain