AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG— 510(k) K850344

Name: FDA 510(k) clearance K850344
Creator: U.S. Food and Drug Administration
Published: 1985-03-25

Substantially Equivalent

Midwest

FDA 510(k) clearance K850344 for AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG, Substantially Equivalent on 1985-03-25. Applicant: Midwest. Device class: 1.

Clearance details

Applicant: Midwest
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 1985-01-28
Decision date: 1985-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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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.