The following data is part of a premarket notification filed by Mectron S.p.a with the FDA for Piezosurgery White.
| Device ID | K171326 |
| 510k Number | K171326 |
| Device Name: | Piezosurgery White |
| Classification | Drill, Bone, Powered |
| Applicant | Mectron S.p.a via Loreto 15 Carasco, IT 16042 |
| Contact | Franco Zunino |
| Correspondent | Karen E. Warden BackRoads Consulting, Inc PO Box 566 Chesterland, OH 44026 -0566 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-05 |
| Decision Date | 2018-04-13 |
| Summary: | summary |