Device Atlas

Otres Toothbrush Sanitizer Model TB100W

Q: What is the product code of K003517?

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) K003517 · Otres, LLC

Substantially Equivalent

510(k) numberK003517

Submission

Device name: Otres Toothbrush Sanitizer Model TB100W
Applicant: Otres, LLC
Lisle, IL, US
Received: November 14, 2000
Decision date: June 6, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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
K901459	DS60 Toothbrush SanitizerMCF · Traditional	Associated Mills, Inc.	09/17/1990SE
K896481	Purebrush Ultraviolet Toothbrush SanitizerMCF · Traditional	Purebrush Assoc.	05/15/1990SE

Questions and answers

When was Otres Toothbrush Sanitizer Model TB100W cleared by the FDA?

Otres Toothbrush Sanitizer Model TB100W (K003517) received a 510(k) decision of Substantially Equivalent on June 6, 2001, 204 days after the submission was received.

What is the product code of K003517?

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.