DZI — Drill, Bone, Powered Class II
FDA product code DZI covers "Drill, Bone, Powered", a Class II medical device regulated under 21 CFR 872.4120. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DZI
- Device Class
- Class II
- Regulation Number
- 872.4120
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253776 | w and h dentalwerk buermoos | Implantmed Plus II & Piezomed Plus II Module | June 18, 2026 |
| K254163 | nakanishi | VarioSurg 4 | December 23, 2025 |
| K242432 | mectron | MT-Bone | August 19, 2024 |
| K240340 | guangdong jinme medical technology co | Surgical Drive System (Model: ES70, ES90, E8) | July 18, 2024 |
| K231087 | implant direct sybron manufacturing | Guided Surgery Kit | August 16, 2023 |
| K192561 | saeshin precision co | TRAUS SUS20 | July 13, 2020 |
| K200265 | implant direct sybron manufacturing | Surgical Drills | June 30, 2020 |
| K192033 | bennett jacoby, dds, ms | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In | June 9, 2020 |
| K172137 | satelec - acteon group | PIEZOTOME CUBE | May 3, 2018 |
| K171326 | mectron | Piezosurgery White | April 13, 2018 |
| K171958 | mectron | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | January 12, 2018 |
| K152125 | bonart co | Oral Surgery System and Accessories | August 15, 2016 |
| K151248 | mectron | PIEZOSURGERY WHITE | September 4, 2015 |
| K151171 | saeshin precision co | TRAUS SUS10 | September 1, 2015 |
| K150076 | dong il technology | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | June 2, 2015 |
| K133488 | w and h dentalwerk buermoos | PIEZOMED | October 16, 2014 |
| K121620 | dmetec.co | ULTRASONIC SURGERY | December 11, 2012 |
| K122322 | mectron | PIEZOSURGERY TOUCH | December 6, 2012 |
| K113152 | dmetec.co | ULTRASONIC SURGERY MACHINE | June 14, 2012 |
| K112188 | satelec - acteon | PIEZOTOME SOLO | February 3, 2012 |