K242897

Substantially Equivalent

Partial Flex

Applicant: Clemde SA DE CV
Product code: EBI
Advisory panel: Dental
Date received: 2024-09-23
Decision date: 2025-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mexico City, MX

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.