GR-14 Resin System— 510(k) K210298
Substantially EquivalentPro3Dure Medical GmbH
FDA 510(k) clearance K210298 for GR-14 Resin System, Substantially Equivalent on 2021-05-05. Applicant: Pro3Dure Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Pro3Dure Medical GmbH
- Product code
- Code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iserlohn, DE
Recent devices under product code EBI
view allMore clearances from Pro3Dure Medical GmbH
view allAdverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.