dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S— 510(k) K222604
Substantially EquivalentDentona AG
FDA 510(k) clearance K222604 for dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S, Substantially Equivalent on 2023-04-21. Applicant: Dentona AG.
Clearance details
- Applicant
- Dentona AG
- Product code
- Code MQC
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dortmund, DE
Adverse events under product code MQC
product code MQC- Injury
- 377
- Total
- 377
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.