R7— 510(k) K130834

Name: FDA 510(k) clearance K130834
Creator: U.S. Food and Drug Administration
Published: 2013-10-08

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K130834 for R7, Substantially Equivalent on 2013-10-08. Applicant: Cefla S.C.. Device class: 2.

Clearance details

Applicant: Cefla S.C.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2013-03-26
Decision date: 2013-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ormond Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.