NextDent Ortho Flex— 510(k) K221022

Substantially Equivalent

Vertex-Dental B.V.

FDA 510(k) clearance K221022 for NextDent Ortho Flex, Substantially Equivalent on 2022-10-21. Applicant: Vertex-Dental B.V..

Clearance details

Applicant: Vertex-Dental B.V.
Product code: Code MQC
Advisory panel: Unknown
Date received: 2022-04-06
Decision date: 2022-10-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Soesterberg, NL

Download summary PDF View on FDA.gov ↗

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.