SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT— 510(k) K083876

Substantially Equivalent

Cendres & Metaux SA

FDA 510(k) clearance K083876 for SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT, Substantially Equivalent on 2010-02-26. Applicant: Cendres & Metaux SA.

Clearance details

Applicant: Cendres & Metaux SA
Product code: Code NHA
Advisory panel: Dental
Date received: 2008-12-29
Decision date: 2010-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Biel/Bienne, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.