Freeprint denture— 510(k) K200461
Substantially EquivalentDetax GmbH & Co. KG
FDA 510(k) clearance K200461 for Freeprint denture, Substantially Equivalent on 2020-11-16. Applicant: Detax GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Detax GmbH & Co. KG
- 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
- Ettlingen, DE
Recent devices under product code EBI
view allMore clearances from Detax GmbH & Co. KG
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.