turbodent touch
FDA 510(k) K251425 · Mectron S.P.A.
510(k) numberK251425
Submission
- Device name
- turbodent touch
- Applicant
- Mectron S.P.A.
Carasco, IT - Received
- May 8, 2025
- Decision date
- May 9, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code KOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063236 | Beta-PowderKOJ · Traditional | Brainbase Corporation | 02/16/2007SE |
| K042872 | Rondoflex Plus 360KOJ · Special | Kavo America Corporation | 11/23/2004SE |
| K033675 | Prosmile Air Polisher and Prophylaxis PowderKOJ · Traditional | Sirona Dental Systems GmbH | 01/15/2004SE |
| K033215 | PrepairKOJ · Traditional | Danville Materials, Inc. | 01/09/2004SE |
| K024105 | Velopex Aquacut Fluid Abrasion UnitKOJ · Traditional | Velopex International, Inc. | 10/09/2003SE |
| K030292 | Groman PrepmasterKOJ · Traditional | Groman, Inc. | 04/15/2003SE |
| K021450 | Clinpro Prophy PowderKOJ · Traditional | 3M Espe AG Dental Products | 08/01/2002SE |
| K014188 | New Prophy PowderKOJ · Traditional | Dentsply Intl. | 03/15/2002SE |
| K014252 | JetstreamKOJ · Traditional | Deldent , Ltd. | 02/19/2002SE |
| K014249 | JetpolisherKOJ · Traditional | Deldent , Ltd. | 02/19/2002SE |
More from Deldent , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242432 | MT-BoneDZI · Traditional | 08/19/2024SE |
| K231391 | Combi TouchELC · Traditional | 05/15/2023SE |
| 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 turbodent touch cleared by the FDA?
turbodent touch (K251425) received a 510(k) decision of Substantially Equivalent on May 9, 2025, 1 days after the submission was received.
What is the product code of K251425?
The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.