K961235

Substantially Equivalent

SIRIUS 180, 180L, 230, 230L

Applicant: Micro-Mega Societe Anonyme
Product code: EFB
Advisory panel: Dental
Date received: 1996-03-29
Decision date: 1997-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Besancon, FR

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.