Water Pik Sensonic Plaque Removal Instrument
FDA 510(k) K940288 · Teledyne Water Pik
510(k) numberK940288
Submission
- Device name
- Water Pik Sensonic Plaque Removal Instrument
- Applicant
- Teledyne Water Pik
Fort Collins, CO, US - Received
- January 21, 1994
- Decision date
- May 26, 1994
- 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 |
| K970381 | Powered ToothbrushJEQ · Traditional | Emjoi Action USA, Ltd. | 04/18/1997SE |
| 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 |
More from Hukuba Dental Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K970594 | Kalginate Impression MaterialELW · Traditional | 03/31/1997SE |
| K952422 | Elastic Impression CreamELW · Traditional | 08/29/1995SE |
| K944162 | Denar Accuceph Cephalometer Imaging SystemEAG · Traditional | 11/29/1994SE |
| K931380 | Water Pik Plus Plaque Control SystemEFS · Traditional | 09/20/1993SE |
| K905188 | Perio PikEFS · Traditional | 02/15/1991SE |
| K900547 | Water Pik(R) W/Add'L ClaimsEFS · Traditional | 06/15/1990SE |
| K895259 | Pik Pocket(R), Model PP-3EFS · Traditional | 11/01/1989SE |
| K894015 | Water Pik(R)EFS · Traditional | 08/28/1989SE |
Questions and answers
When was Water Pik Sensonic Plaque Removal Instrument cleared by the FDA?
Water Pik Sensonic Plaque Removal Instrument (K940288) received a 510(k) decision of Substantially Equivalent on May 26, 1994, 125 days after the submission was received.
What is the product code of K940288?
The FDA product code is JEQ – Toothbrush, Powered, a Class I (low risk) device regulated under 21 CFR 872.6865.