Cleared Traditional

GUM MASSAGER (K911418) - FDA 510(k) Clearance

Class I Dental device.

K911418 · Burn-Henderson Partnership · Dental device
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Jul 1991
Decision
107d
Days
Class 1
Risk

K911418 is an FDA 510(k) clearance for the GUM MASSAGER. Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by Burn-Henderson Partnership (Aurora, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6650 - 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 Burn-Henderson Partnership devices

Submission Details

510(k) Number K911418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date July 17, 1991
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JET Pick, Massaging
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6650
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.