Newtron Booster
FDA 510(k) K131997 · Satelec - Acteon Group
510(k) numberK131997
Submission
- Device name
- Newtron Booster
- Applicant
- Satelec - Acteon Group
Mt. Laurel, NJ, US - Received
- June 28, 2013
- Decision date
- November 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Guilin Refine Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233922 | SP Newtron Can-A; Module Newtron Can-A Emb; Support Xinetic; NWT Can Slim LED Cord G3…ELC · Traditional | 03/11/2024SE |
| K172137 | Piezotome CubeDZI · Traditional | 05/03/2018SE |
| K131906 | Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen…EBZ · Abbreviated | 04/11/2014SE |
| K132322 | Newtron P5 XS B.LedELC · Traditional | 03/11/2014SE |
| K132267 | Newtron P5, Newtron P5 B.LedELC · Traditional | 03/10/2014SE |
| K131151 | EndocenterELC · Traditional | 01/16/2014SE |
| K113430 | Proultra Piezo UltrasonicELC · Traditional | 02/23/2012SE |
| K111623 | I-Endo DualEBW · Traditional | 01/10/2012SE |
| K072030 | Implant CenterDZI · Traditional | 11/19/2007SE |
| K071424 | Pmax Newtron XSELC · Traditional | 08/24/2007SE |
Questions and answers
When was Newtron Booster cleared by the FDA?
Newtron Booster (K131997) received a 510(k) decision of Substantially Equivalent on November 26, 2013, 151 days after the submission was received.
What is the product code of K131997?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.