Piezosurgery Touch, Piezosurgery White
FDA 510(k) K171958 · Mectron S.P.A.
510(k) numberK171958
Submission
- Device name
- Piezosurgery Touch, Piezosurgery White
- Applicant
- Mectron S.P.A.
Carasco, IT - Received
- June 29, 2017
- Decision date
- January 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Satelec - Acteon Group
| 510(k) | Device | Decision |
|---|---|---|
| K251425 | turbodent touchKOJ · Traditional | 05/09/2025SE |
| K242432 | MT-BoneDZI · Traditional | 08/19/2024SE |
| K231391 | Combi TouchELC · Traditional | 05/15/2023SE |
| K171326 | Piezosurgery WhiteDZI · Traditional | 04/13/2018SE |
| K153743 | Piezosurgery PlusJDX · Traditional | 05/25/2016SE |
| K151248 | Piezosurgery WhiteDZI · Traditional | 09/04/2015SE |
| K151023 | Compact Piezo LEDELC · Traditional | 08/05/2015SE |
| K140965 | Multipiezo Pro, MultipiezoELC · Traditional | 08/20/2014SE |
| K132848 | Piezosurgery FlexJDX · Traditional | 11/29/2013SE |
| K122322 | Piezosurgery TouchDZI · Traditional | 12/06/2012SE |
Questions and answers
When was Piezosurgery Touch, Piezosurgery White cleared by the FDA?
Piezosurgery Touch, Piezosurgery White (K171958) received a 510(k) decision of Substantially Equivalent on January 12, 2018, 197 days after the submission was received.
What is the product code of K171958?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.