dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S— 510(k) K222604

Name: FDA 510(k) clearance K222604
Creator: U.S. Food and Drug Administration
Published: 2023-04-21

Substantially Equivalent

Dentona 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. Device class: Unclassified.

Clearance details

Applicant: Dentona AG
Product code: Code MQC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-08-29
Decision date: 2023-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dortmund, DE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.