Cleared Traditional

K860118 - SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 (FDA 510(k) Clearance)

Class I Dental device.

K860118 · Northern Electric Co. Div. of Sunbeam Corp. · Dental device
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Apr 1986
Decision
94d
Days
Class 1
Risk

K860118 is an FDA 510(k) clearance for the SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Northern Electric Co. Div. of Sunbeam Corp. (Chicago, US). The FDA issued a Cleared decision on April 17, 1986 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3520 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Northern Electric Co. Div. of Sunbeam Corp. devices

Submission Details

510(k) Number K860118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1986
Decision Date April 17, 1986
Days to Decision 94 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFT Cleanser, Denture, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.