Cleared Traditional

K003517 - OTRES TOOTHBRUSH SANITIZER MODEL TB100W

K003517 is an FDA 510(k) clearance for OTRES TOOTHBRUSH SANITIZER MODEL TB100W, manufactured by Otres, LLC. The device is a Class 1 Dental device with product code MCF cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K003517 · Otres, LLC · Dental device
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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

FDA 510(k) Submission Details - K003517

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.

MCF Device Classification - Class 1, General Controls

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.