Combi Touch
FDA 510(k) K231391 · Mectron S.P.A.
510(k) numberK231391
Submission
- Device name
- Combi Touch
- Applicant
- Mectron S.P.A.
Carasco, IT - Received
- May 12, 2023
- Decision date
- May 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K171326 | Piezosurgery WhiteDZI · Traditional | 04/13/2018SE |
| K171958 | Piezosurgery Touch, Piezosurgery WhiteDZI · Traditional | 01/12/2018SE |
| 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 Combi Touch cleared by the FDA?
Combi Touch (K231391) received a 510(k) decision of Substantially Equivalent on May 15, 2023, 3 days after the submission was received.
What is the product code of K231391?
The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.