Cleared Traditional

K862385 - SCHEIN BLEACHING UNIT (FDA 510(k) Clearance)

Class I Dental device.

K862385 · Henry Schein, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.