NextDent Denture 3D+— 510(k) K191497

Substantially Equivalent

Vertex-Dental B.V.

FDA 510(k) clearance K191497 for NextDent Denture 3D+, Substantially Equivalent on 2019-11-01. Applicant: Vertex-Dental B.V..

Clearance details

Applicant: Vertex-Dental B.V.
Product code: Code EBI
Advisory panel: Dental
Date received: 2019-06-05
Decision date: 2019-11-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Soesterberg, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.