MT-Bone
FDA 510(k) K242432 · Mectron S.P.A.
510(k) numberK242432
Submission
- Device name
- MT-Bone
- Applicant
- Mectron S.P.A.
Carasco, IT - Received
- August 16, 2024
- Decision date
- August 19, 2024
- 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 DZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | W&H Dentalwerk Buermoos GmbH | 06/18/2026SE |
| K254163 | VarioSurg 4DZI · Traditional | Nakanishi, Inc. | 12/23/2025SE |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 07/18/2024SE |
| K231087 | Guided Surgery KitDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 08/16/2023SE |
| K192561 | Traus SUS20DZI · Traditional | Saeshin Precision Co., Ltd. | 07/13/2020SE |
| K200265 | Surgical DrillsDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 06/30/2020SE |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional | Bennett Jacoby, Dds, Ms, Inc. | 06/09/2020SE |
| K172137 | Piezotome CubeDZI · Traditional | Satelec - Acteon Group | 05/03/2018SE |
| K171326 | Piezosurgery WhiteDZI · Traditional | Mectron S.P.A. | 04/13/2018SE |
More from Mectron S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K251425 | turbodent touchKOJ · Traditional | 05/09/2025SE |
| 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 MT-Bone cleared by the FDA?
MT-Bone (K242432) received a 510(k) decision of Substantially Equivalent on August 19, 2024, 3 days after the submission was received.
What is the product code of K242432?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.