MW-8000— 510(k) K792304

Substantially Equivalent

Midwest

FDA 510(k) clearance K792304 for MW-8000, Substantially Equivalent on 1979-11-27. Applicant: Midwest.

Clearance details

Applicant: Midwest
Product code: Code EFB
Advisory panel: Dental
Date received: 1979-11-16
Decision date: 1979-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.