SAF (SELF ADJUSTING FILE)— 510(k) K092933

Substantially Equivalent

Redent-Nova , Ltd.

FDA 510(k) clearance K092933 for SAF (SELF ADJUSTING FILE), Substantially Equivalent on 2010-01-14. Applicant: Redent-Nova , Ltd..

Clearance details

Applicant: Redent-Nova , Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2009-09-23
Decision date: 2010-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.