SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220— 510(k) K860118

Substantially Equivalent

Northern Electric Co. Div. of Sunbeam Corp.

FDA 510(k) clearance K860118 for SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220, Substantially Equivalent on 1986-04-17. Applicant: Northern Electric Co. Div. of Sunbeam Corp..

Clearance details

Applicant: Northern Electric Co. Div. of Sunbeam Corp.
Product code: Code EFT
Advisory panel: Dental
Date received: 1986-01-13
Decision date: 1986-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFT

product code EFT

Death: 8
Injury: 267
Total: 275

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.