HERO 642— 510(k) K970649

Substantially Equivalent

Micro-Mega

FDA 510(k) clearance K970649 for HERO 642, Substantially Equivalent on 1997-05-16. Applicant: Micro-Mega.

Clearance details

Applicant: Micro-Mega
Product code: Code EKS
Advisory panel: Dental
Date received: 1997-02-20
Decision date: 1997-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: France, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code EKS

product code EKS

Malfunction: 1,949
Total: 1,949

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.