Cleared Traditional

BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING (K884937) - FDA 510(k) Clearance

Class I Dental device.

K884937 · Grass-Telefactor Product Group · Dental device
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Apr 1989
Decision
137d
Days
Class 1
Risk

K884937 is an FDA 510(k) clearance for the BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING. Classified as Heat Source For Bleaching Teeth (product code EEG), Class I - General Controls.

Submitted by Grass-Telefactor Product Group (W. Conshohocken, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6475 - 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 Grass-Telefactor Product Group devices

Submission Details

510(k) Number K884937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date April 14, 1989
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 127d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EEG Heat Source For Bleaching Teeth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6475
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.