DS60 Toothbrush Sanitizer

FDA 510(k) K901459 · Associated Mills, Inc.

Substantially Equivalent

510(k) numberK901459

Submission

Device name
DS60 Toothbrush Sanitizer
Applicant
Associated Mills, Inc.
Chicago, IL, US
Received
March 28, 1990
Decision date
September 17, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MCF – Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Device class
Class I (low risk)
Regulation
21 CFR 872.6855
Specialty
Dental

Other 510(k)s with product code MCF

510(k)DeviceApplicantDecision
K023662Prosonic Ultraviolet Toothbrush SanitizerMCF · Traditional Hwadong International Company , Ltd.05/28/2003SE
K021258Germ Terminator GT 100 Toothbrush SanitizerMCF · Traditional Germ Terminator Corporation05/10/2002SE
K003517Otres Toothbrush Sanitizer Model TB100WMCF · Traditional Otres, LLC06/06/2001SE
K896481Purebrush Ultraviolet Toothbrush SanitizerMCF · Traditional Purebrush Assoc.05/15/1990SE

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Questions and answers

When was DS60 Toothbrush Sanitizer cleared by the FDA?

DS60 Toothbrush Sanitizer (K901459) received a 510(k) decision of Substantially Equivalent on September 17, 1990, 173 days after the submission was received.

What is the product code of K901459?

The FDA product code is MCF – Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile, a Class I (low risk) device regulated under 21 CFR 872.6855.