DEFLEX— 510(k) K113608

Substantially Equivalent

Nuxen S.R.L.

FDA 510(k) clearance K113608 for DEFLEX, Substantially Equivalent on 2012-04-10. Applicant: Nuxen S.R.L..

Clearance details

Applicant: Nuxen S.R.L.
Product code: Code EBI
Advisory panel: Dental
Date received: 2011-12-06
Decision date: 2012-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buenos Aires, AR

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.