Powered Toothbrush
FDA 510(k) K970381 · Emjoi Action USA, Ltd.
510(k) numberK970381
Submission
- Device name
- Powered Toothbrush
- Applicant
- Emjoi Action USA, Ltd.
Westford, MA, US - Received
- February 3, 1997
- Decision date
- April 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code JEQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200881 | Oral-B iO Test Drive Power Brush Trial Program KitJEQ · Traditional | The Procter & Gamble Company | 08/27/2020SE |
| K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…JEQ · Traditional | Procter & Gamble Co. | 09/15/2014SE |
| K061351 | Oral-B Sonic CompleteJEQ · Traditional | Braun GmbH | 06/05/2006SE |
| K061199 | Oral B Professionalcare Series, Oral B Advancepower SeriesJEQ · Traditional | Braun GmbH | 05/31/2006SE |
| K040416 | Sonicare Advance Toothbrush, Model 4900JEQ · Traditional | Philips Oral Healthcare, Inc. | 07/02/2004SE |
| K022900 | Butler Gum Vari-Clean Power ToothbrushesJEQ · Traditional | John O. Butler Co. | 11/14/2002SE |
| K012914 | Sonicwave Sonic Plaque RemoverJEQ · Traditional | Homedics, Inc. | 10/01/2001SE |
| K943942 | Trav-Ler KitJEQ · Traditional | John O. Butler Co. | 03/08/1995SESK |
| K945248 | Hukuba Hyg Electric Ionic ToothbrushJEQ · Traditional | Hukuba Dental Corp. | 01/26/1995SE |
| K944084 | Jeneric/Pentron P0WERED ToothbrustJEQ · Traditional | Jeneric/Pentron, Inc. | 12/20/1994SE |
Questions and answers
When was Powered Toothbrush cleared by the FDA?
Powered Toothbrush (K970381) received a 510(k) decision of Substantially Equivalent on April 18, 1997, 74 days after the submission was received.
What is the product code of K970381?
The FDA product code is JEQ – Toothbrush, Powered, a Class I (low risk) device regulated under 21 CFR 872.6865.