Cleared Traditional

K860264 - SCHERER PORTABLE TOOTH POLISHER

K860264 is an FDA 510(k) clearance for SCHERER PORTABLE TOOTH POLISHER, manufactured by Scherer Laboratories, Inc.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K860264 · Scherer Laboratories, Inc. · Dental device
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Jun 1986
Decision
150d
Days
Class 1
Risk

K860264 is an FDA 510(k) clearance for the SCHERER PORTABLE TOOTH POLISHER. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Scherer Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on June 26, 1986 after a review of 150 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - 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 Scherer Laboratories, Inc. devices

FDA 510(k) Submission Details - K860264

510(k) Number K860264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1986
Decision Date June 26, 1986
Days to Decision 150 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 128d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

JEQ Device Classification - Class 1, General Controls

Product Code JEQ Toothbrush, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
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.