NextDent Ortho Flex— 510(k) K221022

Name: FDA 510(k) clearance K221022
Creator: U.S. Food and Drug Administration
Published: 2022-10-21

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.. Device class: Unclassified.

Clearance details

Applicant: Vertex-Dental B.V.
Product code: Product code MQC
Device class: Unclassified
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 ↗

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K251252 — NOBILCAM IMPAK Disc2025-08-01
K241729 — Hard Splint & Thermo-Adaptive Splint2025-03-18

More clearances from Vertex-Dental B.V.

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K241071 — NextDent Jet Denture Base; NextDent Jet Denture Teeth2024-09-04
K231388 — NextDent Base2023-10-20
K191497 — NextDent Denture 3D+2019-11-01
K162572 — NextDent Denture, E-Denture2017-06-30
K123220 — VERTEX THERMOSENS RIGID2013-03-01

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.