Cleared Traditional

K901459 - DS60 TOOTHBRUSH SANITIZER
(FDA 510(k) Clearance)

Sep 1990
Decision
173d
Days
Class 1
Risk

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

Submitted by Associated Mills, Inc. (Chicago, US). The FDA issued a Cleared decision on September 17, 1990, 173 days after receiving the submission on March 28, 1990.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6855.

Submission Details

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

Device Classification

Product Code MCF — Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.6855