Device Atlas

Purebrush Ultraviolet Toothbrush Sanitizer

Q: What is the product code of K896481?

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.

FDA 510(k) K896481 · Purebrush Assoc.

Substantially Equivalent

510(k) numberK896481

Submission

Device name: Purebrush Ultraviolet Toothbrush Sanitizer
Applicant: Purebrush Assoc.
Washington, DC, US
Received: November 15, 1989
Decision date: May 15, 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)	Device	Applicant	Decision
K023662	Prosonic Ultraviolet Toothbrush SanitizerMCF · Traditional	Hwadong International Company , Ltd.	05/28/2003SE
K021258	Germ Terminator GT 100 Toothbrush SanitizerMCF · Traditional	Germ Terminator Corporation	05/10/2002SE
K003517	Otres Toothbrush Sanitizer Model TB100WMCF · Traditional	Otres, LLC	06/06/2001SE
K901459	DS60 Toothbrush SanitizerMCF · Traditional	Associated Mills, Inc.	09/17/1990SE

Questions and answers

When was Purebrush Ultraviolet Toothbrush Sanitizer cleared by the FDA?

Purebrush Ultraviolet Toothbrush Sanitizer (K896481) received a 510(k) decision of Substantially Equivalent on May 15, 1990, 181 days after the submission was received.

What is the product code of K896481?

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.