Cleared Traditional

K862385 - SCHEIN BLEACHING UNIT

K862385 is an FDA 510(k) clearance for SCHEIN BLEACHING UNIT, manufactured by Henry Schein, Inc.. The device is a Class 1 Dental device with product code EEG cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K862385 · Henry Schein, Inc. · Dental device
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Oct 1986
Decision
128d
Days
Class 1
Risk

K862385 is an FDA 510(k) clearance for the SCHEIN BLEACHING UNIT. Classified as Heat Source For Bleaching Teeth (product code EEG), Class I - General Controls.

Submitted by Henry Schein, Inc. (Port Washington, US). The FDA issued a Cleared decision on October 30, 1986 after a review of 128 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 Henry Schein, Inc. devices

FDA 510(k) Submission Details - K862385

510(k) Number K862385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1986
Decision Date October 30, 1986
Days to Decision 128 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 127d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

EEG Device Classification - Class 1, General Controls

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.