Cleared Traditional

DOCTOR KOLYNOS TOOTHBRUSH (K882572) - FDA 510(k) Clearance

Class I Dental device.

K882572 · Whitehall Laboratories, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
299d
Days
Class 1
Risk

K882572 is an FDA 510(k) clearance for the DOCTOR KOLYNOS TOOTHBRUSH. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Whitehall Laboratories, Inc. (New York, US). The FDA issued a Cleared decision on April 17, 1989 after a review of 299 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 Whitehall Laboratories, Inc. devices

Submission Details

510(k) Number K882572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1988
Decision Date April 17, 1989
Days to Decision 299 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 127d · This submission: 299d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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.