PIEZOSURGERY WHITE
FDA 510(k) clearance K151248 · decided 2015-09-04
Clearance details
- K-number
- K151248
- Device name
- PIEZOSURGERY WHITE
- Applicant
- Mectron S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2015-05-11
- Decision date
- 2015-09-04
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- DZI
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Carasco, IT
- Third-party review
- No
- Expedited review
- No
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| TRAUS SUS20 (K192561) | Saeshin Precision Co., Ltd. | 2020-07-13 |
| Surgical Drills (K200265) | Implant Direct Sybron Manufacturing, LLC | 2020-06-30 |
| Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip (K192033) | Bennett Jacoby, Dds, Ms, Inc. | 2020-06-09 |
| PIEZOTOME CUBE (K172137) | Satelec - Acteon Group | 2018-05-03 |
| Piezosurgery White (K171326) | Mectron S.P.A. | 2018-04-13 |
| PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (K171958) | Mectron S.P.A. | 2018-01-12 |
Recalls involving this device
No recalls on record reference this clearance.