Pmax Newtron XS
FDA 510(k) K071424 · Satelec - Acteon Group
510(k) numberK071424
Submission
- Device name
- Pmax Newtron XS
- Applicant
- Satelec - Acteon Group
Mt. Laurel, NJ, US - Received
- May 23, 2007
- Decision date
- August 24, 2007
- 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.
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| 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 |
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| K131151 | EndocenterELC · Traditional | 01/16/2014SE |
| K131997 | Newtron BoosterELC · Traditional | 11/26/2013SE |
| K113430 | Proultra Piezo UltrasonicELC · Traditional | 02/23/2012SE |
| K111623 | I-Endo DualEBW · Traditional | 01/10/2012SE |
| K072030 | Implant CenterDZI · Traditional | 11/19/2007SE |
Questions and answers
When was Pmax Newtron XS cleared by the FDA?
Pmax Newtron XS (K071424) received a 510(k) decision of Substantially Equivalent on August 24, 2007, 93 days after the submission was received.
What is the product code of K071424?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.