SIRIUS 10, 10L, 40, 40L— 510(k) K961275

Substantially Equivalent

Micro-Mega Societe Anonyme

FDA 510(k) clearance K961275 for SIRIUS 10, 10L, 40, 40L, Substantially Equivalent on 1997-01-17. Applicant: Micro-Mega Societe Anonyme.

Clearance details

Applicant: Micro-Mega Societe Anonyme
Product code: Code EFB
Advisory panel: Dental
Date received: 1996-04-03
Decision date: 1997-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Besancon, FR

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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.