Cleanse.Freshen.Go; Aligner Cleansing Towelette and Dental Appliance Cleanser
FDA 510(k) K080631 · Oral Health Technologies, LLC
510(k) numberK080631
Submission
- Device name
- Cleanse.Freshen.Go; Aligner Cleansing Towelette and Dental Appliance Cleanser
- Applicant
- Oral Health Technologies, LLC
Danville, CA, US - Received
- March 5, 2008
- Decision date
- May 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051342 | Medical InterporousEFT · Traditional | Bonyf AG | 06/02/2006SE |
| K000996 | Trubyte Denture Cleanser/Polishing CompoundEFT · Traditional | Dentsply Intl. | 06/16/2000SE |
| K942203 | OTC Denture CleanserEFT · Traditional | Combe, Inc. | 08/10/1994SE |
| K930337 | Profast(R)-Denture CleanserEFT · Traditional | Fittydent-Altwirth & Schmitt GmbH | 09/07/1993SE |
| K914257 | Denture Product XEFT · Traditional | Essential Dental Systems, Inc. | 01/13/1993SE |
| K925259 | CFR MonographEFT · Traditional | Combe, Inc. | 01/11/1993SE |
| K902838 | Denture Dynamic's Denture MagicEFT · Traditional | Denture Dynamic'S, Inc. | 09/06/1990SE |
| K903686 | Argilite 4 Gold Alloy for PorcelainEFT · Traditional | Argen Precious Metals, Inc. | 08/29/1990SE |
| K895345 | Orad Toothbrush CleanerEFT · Traditional | Orad, Inc. | 03/07/1990SE |
| K890043 | Dentclean Concentrated Denture CleanserEFT · Traditional | K-P Co. | 06/07/1989SE |
Questions and answers
When was Cleanse.Freshen.Go; Aligner Cleansing Towelette and Dental Appliance Cleanser cleared by the FDA?
Cleanse.Freshen.Go; Aligner Cleansing Towelette and Dental Appliance Cleanser (K080631) received a 510(k) decision of Substantially Equivalent on May 23, 2008, 79 days after the submission was received.
What is the product code of K080631?
The FDA product code is EFT – Cleanser, Denture, Over The Counter, a Class I (low risk) device regulated under 21 CFR 872.3520.