U-STYLE ADAPTER— 510(k) K800735

Substantially Equivalent

American Midwest

FDA 510(k) clearance K800735 for U-STYLE ADAPTER, Substantially Equivalent on 1980-04-10. Applicant: American Midwest.

Clearance details

Applicant: American Midwest
Product code: Code EGS
Advisory panel: Dental
Date received: 1980-04-02
Decision date: 1980-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.