Cleared Traditional

OTRES TOOTHBRUSH SANITIZER MODEL TB100W (K003517) - FDA 510(k) Clearance

Class I Dental device.

K003517 · Otres, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
204d
Days
Class 1
Risk

K003517 is an FDA 510(k) clearance for the OTRES TOOTHBRUSH SANITIZER MODEL TB100W. Classified as Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile (product code MCF), Class I - General Controls.

Submitted by Otres, LLC (Lisle, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 204 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 Otres, LLC devices

Submission Details

510(k) Number K003517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2000
Decision Date June 06, 2001
Days to Decision 204 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 127d · This submission: 204d
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.