SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..— 510(k) K111390

Substantially Equivalent

Cendres & Metaux SA

FDA 510(k) clearance K111390 for SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.., Substantially Equivalent on 2011-09-12. Applicant: Cendres & Metaux SA.

Clearance details

Applicant: Cendres & Metaux SA
Product code: Code NHA
Advisory panel: Dental
Date received: 2011-05-18
Decision date: 2011-09-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Biel/Bienne, CH

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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.