Toothbrush Wash
FDA 510(k) K994144 · Cal Huech, Inc.
510(k) numberK994144
Submission
- Device name
- Toothbrush Wash
- Applicant
- Cal Huech, Inc.
Warner Robins, GA, US - Received
- December 7, 1999
- Decision date
- March 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EFW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130186 | Dentek Easy Brush with FluorideEFW · Traditional | Den Tek Oral Care, Inc. | 07/15/2013SE |
| K121165 | Beam Brush/Beam AppEFW · Traditional | Beam Technologies, LLC | 06/21/2012SE |
| K102871 | Silver Care Anitbacterial ToothbrushEFW · Traditional | Piave Spazzolificio S.P.A. | 10/03/2011SE |
| K073224 | Oral-B Sub-Brand Manual ToothbrushEFW · Traditional | Procter & Gamble | 02/06/2008SE |
| K021383 | Zeodyne Toothbrush with Agion AntimicrobialEFW · Traditional | Agion Technologies, LLC | 07/17/2002SE |
| K020776 | Medoral Hygienic Toothbrush with Dentosan FilamentsEFW · Traditional | Coronet Group North America, LLC | 06/03/2002SE |
| K000290 | Lazersmile, LazerwhiteEFW · Traditional | Biolase Technology, Inc. | 04/14/2000SE |
| K992435 | Bacti-Stop Toothbrush Cleaner and SanitizerEFW · Traditional | Azo Enterprises | 10/15/1999SE |
| K980995 | Plaq-Ataq-IEFW · Traditional | Ethicare | 08/20/1998SE |
| K974761 | Butler Antibacterial Interdental ToothbrushEFW · Traditional | John O. Butler Co. | 06/16/1998SE |
Questions and answers
When was Toothbrush Wash cleared by the FDA?
Toothbrush Wash (K994144) received a 510(k) decision of Substantially Equivalent on March 2, 2000, 86 days after the submission was received.
What is the product code of K994144?
The FDA product code is EFW – Toothbrush, Manual, a Class I (low risk) device regulated under 21 CFR 872.6855.