Cleared Traditional

PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER (K896481) - FDA 510(k) Clearance

Class I Dental device.

K896481 · Purebrush Assoc. · Dental device
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May 1990
Decision
181d
Days
Class 1
Risk

K896481 is an FDA 510(k) clearance for the PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER. Classified as Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile (product code MCF), Class I - General Controls.

Submitted by Purebrush Assoc. (Washington, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 181 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 Purebrush Assoc. devices

Submission Details

510(k) Number K896481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1989
Decision Date May 15, 1990
Days to Decision 181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 127d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MCF Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile
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.