CFR Monograph
FDA 510(k) K925259 · Combe, Inc.
510(k) numberK925259
Submission
- Device name
- CFR Monograph
- Applicant
- Combe, Inc.
White Plains, NY, US - Received
- October 19, 1992
- Decision date
- January 11, 1993
- 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 |
|---|---|---|---|
| K080631 | Cleanse.Freshen.Go; Aligner Cleansing Towelette and Dental Appliance CleanserEFT · Traditional | Oral Health Technologies, LLC | 05/23/2008SE |
| 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 |
| 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 |
More from K-P Co.
| 510(k) | Device | Decision |
|---|---|---|
| K171855 | External Moisturizing GelNUC · Special | 07/21/2017SE |
| K150615 | Vaginal Moisturizing GelNUC · Traditional | 05/01/2015SE |
| K141718 | Internal Hydrating GelNUC · Traditional | 11/13/2014SE |
| K942203 | OTC Denture CleanserEFT · Traditional | 08/10/1994SE |
| K863375 | Sea-BondKXX · Traditional | 09/19/1986SE |
| K780719 | Fungus Fighter InsolesKYS · Traditional | 10/10/1978SE |
| K770413 | Cushions, Denture Adhesive, All-DayEHS · Traditional | 06/24/1977SE |
| K770175 | Sea-Bond Adhevise Denture CushionsKKX · Traditional | 02/04/1977SE |
Questions and answers
When was CFR Monograph cleared by the FDA?
CFR Monograph (K925259) received a 510(k) decision of Substantially Equivalent on January 11, 1993, 84 days after the submission was received.
What is the product code of K925259?
The FDA product code is EFT – Cleanser, Denture, Over The Counter, a Class I (low risk) device regulated under 21 CFR 872.3520.