TENDER FIBER— 510(k) K063170

Substantially Equivalent

Micerium S.P.A.

FDA 510(k) clearance K063170 for TENDER FIBER, Substantially Equivalent on 2007-01-12. Applicant: Micerium S.P.A..

Clearance details

Applicant: Micerium S.P.A.
Product code: Code EBI
Advisory panel: Dental
Date received: 2006-10-18
Decision date: 2007-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avegno, Genoa, IT

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.