Oral-B Sonic Complete
FDA 510(k) K061351 · Braun GmbH
510(k) numberK061351
Submission
- Device name
- Oral-B Sonic Complete
- Applicant
- Braun GmbH
Boston, MA, US - Received
- May 15, 2006
- Decision date
- June 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K944084 | Jeneric/Pentron P0WERED ToothbrustJEQ · Traditional | Jeneric/Pentron, Inc. | 12/20/1994SE |
More from Jeneric/Pentron, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061199 | Oral B Professionalcare Series, Oral B Advancepower SeriesJEQ · Traditional | 05/31/2006SE |
| K060006 | Braun Thermoscan Irt 2000 Infrared Ear ThermometerFLL · Special | 01/31/2006SE |
| K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt…FLL · Abbreviated | 10/24/2003SE |
| K012035 | Braun Precision Sensor Pro, Model BP 2590DXN · Special | 07/27/2001SE |
| K003732 | Braun Precision Sensor, Model BP 2000 SeriesDXN · Traditional | 05/16/2001SE |
| K992468 | Braun Thermoscan PRO3000 Infared ThermometerFLL · Traditional | 10/20/1999SE |
| K983295 | Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520FLL · Traditional | 03/15/1999SE |
| K844339 | Braun Dental Center OC-3EFS · Traditional | 02/08/1985SE |
Questions and answers
When was Oral-B Sonic Complete cleared by the FDA?
Oral-B Sonic Complete (K061351) received a 510(k) decision of Substantially Equivalent on June 5, 2006, 21 days after the submission was received.
What is the product code of K061351?
The FDA product code is JEQ – Toothbrush, Powered, a Class I (low risk) device regulated under 21 CFR 872.6865.