Orad Toothbrush Cleaner

FDA 510(k) K895345 · Orad, Inc.

Substantially Equivalent

510(k) numberK895345

Submission

Device name
Orad Toothbrush Cleaner
Applicant
Orad, Inc.
Modesto, CA, US
Received
August 31, 1989
Decision date
March 7, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EFT – Cleanser, Denture, Over The Counter
Device class
Class I (low risk)
Regulation
21 CFR 872.3520
Specialty
Dental

Other 510(k)s with product code EFT

510(k)DeviceApplicantDecision
K080631Cleanse.Freshen.Go; Aligner Cleansing Towelette and Dental Appliance CleanserEFT · Traditional Oral Health Technologies, LLC05/23/2008SE
K051342Medical InterporousEFT · Traditional Bonyf AG06/02/2006SE
K000996Trubyte Denture Cleanser/Polishing CompoundEFT · Traditional Dentsply Intl.06/16/2000SE
K942203OTC Denture CleanserEFT · Traditional Combe, Inc.08/10/1994SE
K930337Profast(R)-Denture CleanserEFT · Traditional Fittydent-Altwirth & Schmitt GmbH09/07/1993SE
K914257Denture Product XEFT · Traditional Essential Dental Systems, Inc.01/13/1993SE
K925259CFR MonographEFT · Traditional Combe, Inc.01/11/1993SE
K902838Denture Dynamic's Denture MagicEFT · Traditional Denture Dynamic'S, Inc.09/06/1990SE
K903686Argilite 4 Gold Alloy for PorcelainEFT · Traditional Argen Precious Metals, Inc.08/29/1990SE
K890043Dentclean Concentrated Denture CleanserEFT · Traditional K-P Co.06/07/1989SE

Questions and answers

When was Orad Toothbrush Cleaner cleared by the FDA?

Orad Toothbrush Cleaner (K895345) received a 510(k) decision of Substantially Equivalent on March 7, 1990, 188 days after the submission was received.

What is the product code of K895345?

The FDA product code is EFT – Cleanser, Denture, Over The Counter, a Class I (low risk) device regulated under 21 CFR 872.3520.