Cleared Traditional

K901459 - DS60 TOOTHBRUSH SANITIZER

K901459 is an FDA 510(k) clearance for DS60 TOOTHBRUSH SANITIZER, manufactured by Associated Mills, Inc.. The device is a Class 1 Dental device with product code MCF cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K901459 · Associated Mills, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
173d
Days
Class 1
Risk

K901459 is an FDA 510(k) clearance for the DS60 TOOTHBRUSH SANITIZER. Classified as Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile (product code MCF), Class I - General Controls.

Submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on September 17, 1990 after a review of 173 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 Associated Mills, Inc. devices

FDA 510(k) Submission Details - K901459

510(k) Number K901459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1990
Decision Date September 17, 1990
Days to Decision 173 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 127d · This submission: 173d
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.