Cleared Traditional

PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER (K023662) - FDA 510(k) Clearance

Class I Dental device.

K023662 · Hwadong International Company , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
209d
Days
Class 1
Risk

K023662 is an FDA 510(k) clearance for the PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER. Classified as Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile (product code MCF), Class I - General Controls.

Submitted by Hwadong International Company , Ltd. (Ft. Lauderdale, US). The FDA issued a Cleared decision on May 28, 2003 after a review of 209 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 Hwadong International Company , Ltd. devices

Submission Details

510(k) Number K023662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2002
Decision Date May 28, 2003
Days to Decision 209 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 127d · This submission: 209d
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.